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FDA 510(k)

POST AURICULAR HEARING AID 46PP-PC SUMMIT

K-Number: K874707 · 1987-12-11

ApplicantRichards Medical Co., Inc.
Decision Date1987-12-11
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

POST AURICULAR HEARING AID 46PP-PC SUMMIT is the device name listed in this FDA 510(k) record. The listed applicant is Richards Medical Co., Inc.. It received FDA 510(k) clearance on 1987-12-11 under 510(k) number K874707. 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 POST AURICULAR HEARING AID 46PP-PC SUMMIT?

POST AURICULAR HEARING AID 46PP-PC SUMMIT is a medical device that received FDA 510(k) clearance on 1987-12-11. The listed applicant is Richards Medical Co., Inc.. The 510(k) number is K874707.

When did POST AURICULAR HEARING AID 46PP-PC SUMMIT receive FDA 510(k) clearance?

POST AURICULAR HEARING AID 46PP-PC SUMMIT received FDA 510(k) clearance on 1987-12-11, under 510(k) number K874707.

Who is the listed applicant for POST AURICULAR HEARING AID 46PP-PC SUMMIT?

The FDA 510(k) record lists Richards Medical Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POST AURICULAR HEARING AID 46PP-PC SUMMIT?

The FDA product code for POST AURICULAR HEARING AID 46PP-PC SUMMIT is ESD.

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Other records listing Richards Medical Co., Inc. 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.

K896106ROGOZINSKI SPINAL SYSTEM, ADD'L COMPONENTSK900628MODULAR HIP SYSTEMK896580UNI-POLAR HEADK895241INTRAMEDULLARY HIP SCREWK884824TRICON-M TOTAL KNEE SYSTEMK896204ZIRCONIA CERAMIC HEAD ADD'L SIZES

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Related Devices (Code: ESD)

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.

K232999Lyric4 Hearing AidSonova AGK130790LYRIC2Phonak, LLCK081136LYRIC 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.

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