510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Narco Air-Shields

Walker, MI, US

Narco Air-Shields appears in FDA device records in Walker, MI. FDA records list 19 510(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
19
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 19 510(k) clearances for Narco Air-Shields between 1978 and 1982. The busiest year on record is 1979, with 11. The most recent is 1982, with 1.

Clearances by year, as a table
510(k) clearance decisions for Narco Air-Shields, by decision year
YearClearances
19782
197911
19803
19812
19821
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K820114SYSTEM V.HEART RATE/RESPIR. RATE MONIT.DRTSubstantially Equivalent
K810953MODEL 533 PHOTOTHERAPY UNITLBISubstantially Equivalent
K810474PROBE COVERFLLSubstantially Equivalent
K802800NARCO AIR-SHEILDS SYS. 100 MONITOR SYSDXGSubstantially Equivalent
K802126ISOLETTE INCUBATOR C-100FMZSubstantially Equivalent
K792592AMBU UNIVERSAL SUCTION PUMPJCXSubstantially Equivalent
K792499AMBU PAEDI ANAESTHESIA SYSTEMCAISubstantially Equivalent
K792118AIR-SHIELDS RESUSCITATORSBTMSubstantially Equivalent
K792117AIR-SHIELDS HEART RATE MONITORDRTSubstantially Equivalent
K790552AS7 & AS8 MONITORSDRTSubstantially Equivalent
K790551TRANSPORT INCUBATORFPLSubstantially Equivalent
K790733VENTIMETER VENTILATORCBKSubstantially Equivalent
K790732VENTIMETER CONTROLLERCBKSubstantially Equivalent
K790035AMBU SUCTION BOOSTERCBCSubstantially Equivalent
K790137INFANT CARE SYSTEMFMTSubstantially Equivalent
K790036DIGITAL BPMDXOSubstantially Equivalent
K790037SONO TRAK T.M.IYOSubstantially Equivalent
K782152VALVE, AMBU PEEPBYEUnknown
K780458TRANSCUTANEOUS OXYGEN PERFUSION MONITORKLKSubstantially 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