510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Del Mar Avionics

Mchenry, IL, US

Del Mar Avionics appears in FDA device records in Mchenry, IL. FDA records list 54 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
54
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

Showing 50 of 54

FDA records hold 54 510(k) clearances for Del Mar Avionics between 1977 and 1999. The busiest year on record is 1979, with 11. The most recent is 1999, with 1.

Clearances by year, as a table
510(k) clearance decisions for Del Mar Avionics, by decision year
YearClearances
19771
197911
19803
19812
19829
19831
19843
19853
19865
19871
19883
19893
19903
19931
19952
19972
19991
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K990027OMNICORDER, MODEL 464DSHSubstantially Equivalent
K971696SENTINEL RECORDER, MODELS 471/472DXHSubstantially Equivalent
K963174HOLTER DIGICORDER WITH PACER OPTION (MODEL 483)DSHSubstantially Equivalent
K950020HOLTER PACERCORDER(R)DSHSubstantially Equivalent
K942653HOLTER SSR DIGICORDER(TM)DSHSubstantially Equivalent
K922221SPRINT DX, MODEL 5400 EXERCISE STRESS TEST SYSTEMLOSSubstantially Equivalent
K896862MODEL 263 SPECTRASCAN(TM) HOLTER ANALYSIS SYSTEMDSISubstantially Equivalent
K895793MICROPOTENTIAL ANALYZER/SPECTROCARDIOGRAPHY OPTIONDSHSubstantially Equivalent
K894543MODEL 493 SSR-3 THREE CHANNEL SOLID-STATE RECORDERDSISubstantially Equivalent
K891148MODEL 152 DELTA HOLTER ECG ANALYSIS SYSTEMDSISubstantially Equivalent
K884887MODEL 499 SSR ANALYSIS SYSTEMDSISubstantially Equivalent
K884330MODEL 463 ELECTROCARDIORECORDER RECORDERDSHSubstantially Equivalent
K884009MODEL 459 ELECTROCARDIOCORDER RECORDERDSHSubstantially Equivalent
K874313MODEL 492 SSR (TM) RECORDERDSHSubstantially Equivalent
K872658MODEL 980-CARDIOSCOPE AT-3 ELECTROCARDIOGRAPHDPSSubstantially Equivalent
K863387MULTIPLEDXKSubstantially Equivalent
K863652MODEL 456 ELECTROCARDIORECORDER RECORDERDPSSubstantially Equivalent
K860471DEL AMR MODEL 250 CARDIODISPLAY HOLTER SCANNERDSISubstantially Equivalent
K860470DEL MAR MODEL 750 INNOVATOR HOLTER MANAGEMENT SYSTDSISubstantially Equivalent
K854269MODEL 509A PHYSIOCORDER AMBULATORY RECORDERDSHSubstantially Equivalent
K854268DEL MAR AVIONICS 5509A PHYSIOSCANNER EEG SCANNERGWQSubstantially Equivalent
K844896DEL MAR AVIONICS 8300 SECTOR IMAGER SYSDXKSubstantially Equivalent
K850044TREADMILL E-17IOLSubstantially Equivalent
K850043CARDIOGUARD STRESS TEST MONITOR 4002DRTSubstantially Equivalent
K841654DEL MAR AVIONICS 509 NEUROCORDER AMBULDSHSubstantially Equivalent
K841653DEL MAR AVIONICS 5509 NEURO-SCANNERGWQSubstantially Equivalent
K840622CARDIO EXPRESS 100 HOLTER SCANNERDSISubstantially Equivalent
K833661ELECTROCARDIOCORDER RECORDER 453DSHSubstantially Equivalent
K822815MODEL 700 GASTROREFLUX MONITOR/AMALYZERFFTSubstantially Equivalent
K822751DEL MAR AVIONICS MODEL 551 NEUROCORDERSubstantially Equivalent
K822624O.T.E. BIOMEDICA B.A.S.I.S. MODEL 2381IKNSubstantially Equivalent
K822700DEL MAR MODEL 5500 EEG SCANNERGWQSubstantially Equivalent
K820653OTE BIOMEDICA BERG FOURIER ANALYZEROLTSubstantially Equivalent
K820779OTE BIOMEDICAL #1296 - 16 CHAN. RECORDGWQSubstantially Equivalent
K820605OTE BIOMEDICA NEUROGRAPH 18GWQSubstantially Equivalent
K820604OTE BIOMEDICA NEUROGRAPH 9GWQSubstantially Equivalent
K820603OTE BIOMEDICA NEUROGRAPH 14GWQSubstantially Equivalent
K813222MODEL 4200 ELLESTAD STRESS TEST ANALYZERDXGSubstantially Equivalent
K811122DEL MAR AVIONICS MODELS 9400 & 9401DSISubstantially Equivalent
K801831EVALUATOR #9500 DYNAMIC ELEC/SCANNERDSISubstantially Equivalent
K801832MODEL 9200 VIS-U-SCANDSHSubstantially Equivalent
K801830MODEL 9300 ELECTROCARDIOVALIDATORDSFSubstantially Equivalent
K792079MODEL 447 ELECTROCARDIOCORDERDSHSubstantially Equivalent
K792078MODEL 449 ELECTROCARDIOCORDERDSHSubstantially Equivalent
K792076MODEL 448 PACERCORDERDSHSubstantially Equivalent
K792074MODEL 674 PACER ANALYZERDTCSubstantially Equivalent
K792080MODEL 656 ARRHYTHMIA ANALYZERDXGSubstantially Equivalent
K792077MODEL 1981 PRESSUROMETER DATA ANALYSISDSKSubstantially Equivalent
K792075MODEL 1978 PRESSUROMETER III AMBULATORYDXNSubstantially Equivalent
K792071DCG DATA TERMINALSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain