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

Orlando, FL, US

Invivo Research, Inc. appears in FDA device records in Orlando, FL. FDA records list 14 510(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
14
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 14 510(k) clearances for Invivo Research, Inc. between 1989 and 2005. The busiest year on record is 1998, with 3. The most recent is 2005, with 2.

Clearances by year, as a table
510(k) clearance decisions for Invivo Research, Inc., by decision year
YearClearances
19891
19941
19952
19961
19983
20001
20021
20042
20052
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K050399MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 3160MWISubstantially Equivalent
K043354MODULAR TELEMETRY SYSTEM FOR THE VISION TELEPAK, MODEL 20701DRTSubstantially Equivalent
K041918INTEGRATED PATIENT MONITORING SYSTEMMWISubstantially Equivalent
K040915MAGNITUDE 3150M MRI PATIENT MONITOR, MODEL 3150MMWISubstantially Equivalent
K002604CENTURION 2000 CENTRAL STATION ARRHYTHMIA PATIENT MONITORING SYSTEMDSISubstantially Equivalent
K002030OMNI-TRAK 3150/3155A SERIES MONITOR WITH ANESTHETIC AGENT, MODEL 3155A SERIESMWISubstantially Equivalent
K980045CENTURION CENTRAL STATION ARRHYTHMIA PATIENT MONITORING SYSTEMDSISubstantially Equivalent
K974581MILLENNIA 3500 SERIES MONITOR WITH ANTHESTHETIC AGENTDRTSubstantially Equivalent
K971840OMNI-TRAK MODEL 3150 SERIES PATIENT MONITORING SYSTEMMHXSubstantially Equivalent
K955045OMNI-TRAK PATIENT MONITORING SYSTEMDPSSubstantially Equivalent
K945138OMEGA 5600 SERIES NON-INVASIVE BLOOD PRESSURE MONITORSDXNSubstantially Equivalent
K935020OMNI-TRAC MODIFICATIONMLDSubstantially Equivalent
K936051OMNI-CENTRAL STATION MONITORDRTSubstantially Equivalent
K890817OMNI-TRAK (PATIENT MONITOR)CCKSubstantially 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