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FDA 510(k)

EMSEE LABS MODE M

K-Number: K944985 · 1994-12-30

ApplicantEmsee Lab of Florida
Decision Date1994-12-30
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

EMSEE LABS MODE M is the device name listed in this FDA 510(k) record. The listed applicant is Emsee Lab of Florida. It received FDA 510(k) clearance on 1994-12-30 under 510(k) number K944985. 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 EMSEE LABS MODE M?

EMSEE LABS MODE M is a medical device that received FDA 510(k) clearance on 1994-12-30. The listed applicant is Emsee Lab of Florida. The 510(k) number is K944985.

When did EMSEE LABS MODE M receive FDA 510(k) clearance?

EMSEE LABS MODE M received FDA 510(k) clearance on 1994-12-30, under 510(k) number K944985.

Who is the listed applicant for EMSEE LABS MODE M?

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

What is the FDA product code for EMSEE LABS MODE M?

The FDA product code for EMSEE LABS MODE M is ESD.

Related Clinical Trials

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Other records listing Emsee Lab of Florida 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.

K944986EMSEE LABS MODEL CK944984EMSEE LABS MODEL S

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

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

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