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

Mchenry, IL, US

Danavox, Inc. appears in FDA device records in Mchenry, IL. FDA records list 26 510(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
26
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 26 510(k) clearances for Danavox, Inc. between 1977 and 1994. The busiest year on record is 1978, with 5. The most recent is 1994, with 1.

Clearances by year, as a table
510(k) clearance decisions for Danavox, Inc., by decision year
YearClearances
19772
19785
19793
19802
19813
19824
19833
19842
19851
19941
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K940608155 PP AGC-IESDSubstantially Equivalent
K851069BODY TYPE HEARING AID 107SESDSubstantially Equivalent
K843791BEHIND-THE-EAR 123 VTHESDSubstantially Equivalent
K833486IN-THE-EAR HEARING AID MODELESDSubstantially Equivalent
K832751BEHIND-THE-EAR SERIES 125ESDSubstantially Equivalent
K832326BEHIND-THE-EAR #123 AGCIESDSubstantially Equivalent
K823073101M IN-THE-EARESDSubstantially Equivalent
K823531BEHIND-THE-EAR HEARING AID #8003ESDSubstantially Equivalent
K822655BEHIND-THE-EAR MODEL 115 V AGC O WESDSubstantially Equivalent
K822619BEHIND-THE-EAR MODEL 115PPPCWESDSubstantially Equivalent
K822387BEHIND-THE-EAR MODEL SERIES 123ESDSubstantially Equivalent
K812939IN-THE-EAR MODEL 101MESDSubstantially Equivalent
K812938IN-THE-EAR MODEL 821ESDSubstantially Equivalent
K812937BEHIND-THE-EAR MODEL 115ESDSubstantially Equivalent
K802859BEHIND-THE-EAR HEARING AIDESDSubstantially Equivalent
K800345MODEL 795U BEHIND THE EAR HEARING AIDESDSubstantially Equivalent
K792334BEHINDTHEEAR HEAR. AID MOD. 793U,M,UH,MHESDSubstantially Equivalent
K790539HEARING AID DANAVOX 775VESDSubstantially Equivalent
K790515BEHIND-THE-EAR HEARING AIDESDSubstantially Equivalent
K781881HEARING AID, MODEL 781ESDSubstantially Equivalent
K781596HEARING AID, MODEL 775 PP/AGCESDSubstantially Equivalent
K781595BODY-WORN HEARING AID, MODEL 787PPESDSubstantially Equivalent
K781212HEARING AID, MODEL 783DUESDSubstantially Equivalent
K780546BEHIND-THE-EAR MASKING AMPLIFIER,735SKLWSubstantially Equivalent
K771607HEARING AID MODEL 775ESDSubstantially Equivalent
K770321PERCEPTORESDSubstantially 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