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FDA 510(k)

M25 PP (BEHIND THE EAR)

K-Number: K780919 · 1978-06-14

ApplicantArgosy Intl. (Usa), Inc.
Decision Date1978-06-14
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

M25 PP (BEHIND THE EAR) is the device name listed in this FDA 510(k) record. The listed applicant is Argosy Intl. (Usa), Inc.. It received FDA 510(k) clearance on 1978-06-14 under 510(k) number K780919. 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 M25 PP (BEHIND THE EAR)?

M25 PP (BEHIND THE EAR) is a medical device that received FDA 510(k) clearance on 1978-06-14. The listed applicant is Argosy Intl. (Usa), Inc.. The 510(k) number is K780919.

When did M25 PP (BEHIND THE EAR) receive FDA 510(k) clearance?

M25 PP (BEHIND THE EAR) received FDA 510(k) clearance on 1978-06-14, under 510(k) number K780919.

Who is the listed applicant for M25 PP (BEHIND THE EAR)?

The FDA 510(k) record lists Argosy Intl. (Usa), Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for M25 PP (BEHIND THE EAR)?

The FDA product code for M25 PP (BEHIND THE EAR) is ESD.

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Other records listing Argosy Intl. (Usa), 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.

K823075REXTONK791548REXTON HS(HEARING SYSTEM)K781095HEARING AID, BEHIND THE EARK781096HEARING AID, EYEGLASS, B-12K781094HEARING AID, EYEGLASSK780920MM-CE 11 (BEHIND THE EAR)

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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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