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

Mchenry, IL, US

Birtcher Corp. appears in FDA device records in Mchenry, IL. FDA records list 27 510(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
27
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 27 510(k) clearances for Birtcher Corp. between 1976 and 1988. The busiest year on record is 1985, with 7. The most recent is 1988, with 1.

Clearances by year, as a table
510(k) clearance decisions for Birtcher Corp., by decision year
YearClearances
19761
19773
19781
19791
19802
19826
19831
19841
19857
19863
19881
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K881328MODEL 375 ECGDPSSubstantially Equivalent
K860718ELECTROSURGERY PENCIL, MODEL 767GEISubstantially Equivalent
K860687BIRT-A-SWITCH, DSP PUSH BUTTON, MODEL NO. 768GEISubstantially Equivalent
K854814SURGICAL CAUTERIES MODELS 775-11,12,13,31,32 & 33GEISubstantially Equivalent
K854864BI-POLAR FORCEPSGEISubstantially Equivalent
K850943MODEL 775 BIPOLAR COAGULATORGEISubstantially Equivalent
K850668ELECTROSURGICAL UNIT 774GEISubstantially Equivalent
K844101CARDIO-NEC MODEL 365DPSSubstantially Equivalent
K844104CARDIO ANALYZER MODEL 380LOSSubstantially Equivalent
K850297ELECTROSURGICAL PENCIL HOLDER 720GEISubstantially Equivalent
K844103CARDIOPAC DEFIBRILLATOR 444LDDSubstantially Equivalent
K843221MEGASON MODEL 150IMISubstantially Equivalent
K823491BIRT-A-SWITCH DSP #712GEISubstantially Equivalent
K823488ELECTROCARDIOGRAPH #334DPSSubstantially Equivalent
K823492BIRT-A-PAD #730Substantially Equivalent
K821888AUTOMATIC SINGLE CHANNEL ECG #399DPSSubstantially Equivalent
K82149135MM ANGIOGRAM VIEWER ANALYZERDXJSubstantially Equivalent
K821157HETERODYNAMICIPFSubstantially Equivalent
K821453CARDIOCASSETTE II #363DSHSubstantially Equivalent
K800632MODEL 118 PULSE MEGASONIMISubstantially Equivalent
K800617HYFRECATOR, #733GEISubstantially Equivalent
K781949ELECTROSURGERY MODEL 771GEISubstantially Equivalent
K780755SHORTWAVE DIATHERMY MODEL 802IMJSubstantially Equivalent
K761023SIMULATOR, 10 LEAD ECGDPSSubstantially Equivalent
K770037ELECTROCARDIOGRAPH MODEL 344DPSSubstantially Equivalent
K761231MODEL 738 BIRT-A-PADGEISubstantially Equivalent
K760722BIRT-A-CHUCK DISPOSABLE ELECTR. HANDLEGEISubstantially 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