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Telex Communications, Inc.

Mchenry, IL, US

Telex Communications, Inc. appears in FDA device records in Mchenry, IL. FDA records list 50 510(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
50
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 50 510(k) clearances for Telex Communications, Inc. between 1979 and 1999. The busiest year on record is 1979, with 7. The most recent is 1999, with 1.

Clearances by year, as a table
510(k) clearance decisions for Telex Communications, Inc., by decision year
YearClearances
19797
19803
19822
19831
19843
19854
19861
19872
19901
19916
19926
19935
19942
19952
19962
19971
19981
19991
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K984243TELEX TINNITUS-COMPANIONKLWSubstantially Equivalent
K982683TELEX SELECT 1-40 WITH ADAPTIVE COMPRESSIONEPFSubstantially Equivalent
K964639TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSION-IIESDSubstantially Equivalent
K963915TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSIONESDSubstantially Equivalent
K961143TELEX SELECT 2-40 WITH ADAPTIVE COMPRESSION S2-40ESDSubstantially Equivalent
K954579TELEX 349 MULTI CROS W/ADAPIVE COMPRESSIONESDSubstantially Equivalent
K943961THE MODEL ACAPPELLA IN THE EAR HEARING AIDESDSubstantially Equivalent
K935048ARTISAN PROGRAMMER & HEARING AIDLRBSubstantially Equivalent
K935366BINAURAL HEARING AIDESDSubstantially Equivalent
K933579MEMOREX ARTISAN SYSTEM/ARTISAN PROGRAMMER AND CUSTOM HEARING AIDESDSubstantially Equivalent
K933095351-AGCO BEHIND-THE-EAR HEARING AIDESDSubstantially Equivalent
K931158MEMOREX MODEL 361-AGCO HEARING AIDESDSubstantially Equivalent
K931157BEHIND-THE-EAR HEARING AID, TELEX MODEL 380-PPESDSubstantially Equivalent
K931134BEHIND-THE-EAR HEARING AID, TELEX MODEL 361-PPESDSubstantially Equivalent
K922066TELEX MODEL 28A ITE CUSTOM HEARING AIDESDSubstantially Equivalent
K922065TELEX MODEL M29 ITE CUSTOM HEARING AIDESDSubstantially Equivalent
K915398TDR-5 BINAURAL HEARINGAID/WIRELES FM RECEIVEREPFSubstantially Equivalent
K915397TDR-7 BINAURAL HEARING AID/WIRELESS FM RECIEVEREPFSubstantially Equivalent
K915384TDR-4S MONAURAL HEARING AID/WIRELESS FM RECEIVEREPFSubstantially Equivalent
K915383TDR-4 MONAURAL HEARING AID/WIRELESS FM RECEIVEREPFSubstantially Equivalent
K913495TELEX TDR-7AA BINAURAL HEAR AID/WIRELESS FM RECEPFSubstantially Equivalent
K913494TELEX TDR-4AA MONAURAL HEAR AID/WIRELESS FM RECEPFSubstantially Equivalent
K914418ACT-II BEHIND THE EAR HEARING AIDESDSubstantially Equivalent
K912204TELEX MODEL TLP, IN-THE-EARESDSubstantially Equivalent
K910901FACEPLATE ITE HEARING AID MODEL 28ALRBSubstantially Equivalent
K910900FACEPLATE ITE HEARING AID MODEL TCALRBSubstantially Equivalent
K900846MODEL 366 HEARING AIDESDSubstantially Equivalent
K870435MODEL 350 WIRELESS CROS/CROS LOW OUTPUT HEAR. AIDESDSubstantially Equivalent
K870434MODEL 350 WIRELESS BICROS/MULTICROS HEARING AIDSESDSubstantially Equivalent
K860035MODEL 353C HEARING AIDESDSubstantially Equivalent
K853264HEARING AID MODEL 337DESDSubstantially Equivalent
K853108MODEL 372L HEARING AIDESDSubstantially Equivalent
K850243HEARING AID 365ESDSubstantially Equivalent
K844648MODEL 363C HEARING AIDESDSubstantially Equivalent
K843068HEARING AIDS 372 & 372 AIESDSubstantially Equivalent
K843067TCA HEARING AIDESDSubstantially Equivalent
K840871BEHIND-THE-EAR HEARING AID 2000ESDSubstantially Equivalent
K831197MODEL 343D HEARING AIDESDSubstantially Equivalent
K821132MODEL 28C HEAPING AIDESDSubstantially Equivalent
K820148MODEL 343 HEARING AIDESDSubstantially Equivalent
K792464MODEL 341H (HEARING AID)ESDSubstantially Equivalent
K792463MODEL 339 TELECROS WIRELESS CROSESDSubstantially Equivalent
K792462MODEL 339 TELECROS WIRELESS BICROSESDSubstantially Equivalent
K791601MODEL 336A HEARING AIDSESDSubstantially Equivalent
K791600MODEL 33A HEARING AIDSESDSubstantially Equivalent
K791599MODEL 33DA HEARING AIDSESDSubstantially Equivalent
K791506MODEL 344ESDSubstantially Equivalent
K790412MODEL 337E HEARING AIDESDSubstantially Equivalent
K790355MODEL 342D HEARING AIDSESDSubstantially Equivalent
K790354MODEL 342 HEARING AIDSESDSubstantially 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