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

Buffalo, NY, US

AIRSEP CORP. appears in FDA device records in Buffalo, NY. FDA records list 19 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
19
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 19 510(k) clearances for Airsep Corp. between 1987 and 2015. The busiest year on record is 2000, with 4. The most recent is 2015, with 1.

Clearances by year, as a table
510(k) clearance decisions for Airsep Corp., by decision year
YearClearances
19871
19891
19952
19963
19971
19981
19991
20004
20022
20081
20111
20151
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K150930Deployable Oxygen Generation System-Smaill (DOGS-S)CAWSubstantially Equivalent
K101154CENTROX, RELIANT, ULTROX, AS-D+, AS-E, AS-G, AS-J, AS-K AND AS-LCAWSubstantially Equivalent
K080348OXISCAN II DATA MANAGEMENT SYSTEMDQASubstantially Equivalent
K020324LIFESTYLE OXYGEN CONCENTRATORCAWSubstantially Equivalent
K012037HEALTHLIFE OXYGEN CONCENTRATOR MODEL AS009CAWSubstantially Equivalent
K000963DA VINCHI EEG AND EMG/EP SYSTEMSGWFSubstantially Equivalent
K001579IMPULSE SELECTNFBSubstantially Equivalent
K001467DA VINCHI EMG/EP ISA1004EPGWESubstantially Equivalent
K001013MONET ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHYOLVSubstantially Equivalent
K992283ARTISAN ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHYOLVSubstantially Equivalent
K983002MYSTIQUE ULTRASONIC NEBULIZERCAFSubstantially Equivalent
K960309AIRSEP NEWLIFE DUAL SIX OXYGEN CONCENTRATOR (MODIFICATION)CAWSubstantially Equivalent
K962865REMBRANDT SYSTEMFLSSubstantially Equivalent - Subject to Tracking Reg.
K962766AIRSEP IMPULSENFBSubstantially Equivalent
K943207NITELIFE BI-LEVEL CPAPBZDSubstantially Equivalent
K951882ECO CHECK (ECOVALVE AND OXYGEN MONITOR)CAWSubstantially Equivalent
K944020AIRSEP NEWLIFE AIR OUTLET OPTIONCAFSubstantially Equivalent
K884581RELIANT OXYGEN CONCENTRATORCAWSubstantially Equivalent
K8725344LYF OXYGEN CONCENTRATORCAWSubstantially Equivalent

Registered establishments

FDA registered establishments for Airsep Corp., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
13190443006277965AIRSEP CORP.260 Creekside Dr, Buffalo, NY 14228 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

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