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FDA 510(k)

POWER MANHATTAN II

K-Number: K934446 · 1993-10-08

ApplicantArgosy Electronics
Decision Date1993-10-08
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

POWER MANHATTAN II is the device name listed in this FDA 510(k) record. The listed applicant is Argosy Electronics. It received FDA 510(k) clearance on 1993-10-08 under 510(k) number K934446. 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 POWER MANHATTAN II?

POWER MANHATTAN II is a medical device that received FDA 510(k) clearance on 1993-10-08. The listed applicant is Argosy Electronics. The 510(k) number is K934446.

When did POWER MANHATTAN II receive FDA 510(k) clearance?

POWER MANHATTAN II received FDA 510(k) clearance on 1993-10-08, under 510(k) number K934446.

Who is the listed applicant for POWER MANHATTAN II?

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

What is the FDA product code for POWER MANHATTAN II?

The FDA product code for POWER MANHATTAN II is ESD.

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Other records listing Argosy Electronics 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.

K974242ARGOSY PROGRAMMABLE ONQUEK971699ARGOSY DYNAMEQK961729ARGOSY PROGRAMMABLEK954038K-AMP 16, HI-BAND K-AMP, ULTRA COMPRESSION & HEARING PROTECTION/HEARING INSTRUMENTK952451CLASS D LINEAR WITH ACTIVE TONE CONTROLK952450WIDE DYNAMIC RANGE COMPRESSION WITH ACTIVE TONE CONTROL

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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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