FDA 510(k)

AS-90

K-Number: K923006 · 1993-09-18

Decision Date1993-09-18

Product CodeESD

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

AS-90 is the device name listed in this FDA 510(k) record. The listed applicant is Qualitone. It received FDA 510(k) clearance on 1993-09-18 under 510(k) number K923006. The device is classified under product code ESD. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AS-90?

AS-90 is a medical device that received FDA 510(k) clearance on 1993-09-18. The listed applicant is Qualitone. The 510(k) number is K923006.

When did AS-90 receive FDA 510(k) clearance?

AS-90 received FDA 510(k) clearance on 1993-09-18, under 510(k) number K923006.

Who is the listed applicant for AS-90?

The FDA 510(k) record lists Qualitone as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AS-90?

The FDA product code for AS-90 is ESD.

Other records listing Qualitone as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K961827IN-THE-EAR K955466DYNAMEQ-II OPTION K955359CYBER III OPTION UM, UC312, UC10, UCIC K953884PROPHET K935348ODYSSEY CLINICAL AUDIOMETER K935289PRO FIT-CYBER II OPTION

View all 39 devices →

Related Devices (Code: ESD)

K232999Lyric4 Hearing AidSonova AG K130790LYRIC2Phonak, LLC K081136LYRIC HEARING AIDInsound Medical, Inc.K021867INSOUND XT SERIES HEARING AIDInsound Medical, Inc.K003558TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)Siemens Hearing Instruments, Inc.K984518SONIC INNOVATIONS COMPLETELY-IN-THE-CANAL DSP HEARING AID WITH SOFT SHELLSonic Innovations, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.