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FDA 510(k)

HELP-MATE

K-Number: K813249 · 1981-12-03

ApplicantG & W Applied Science Laboratories
Decision Date1981-12-03
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

HELP-MATE is the device name listed in this FDA 510(k) record. The listed applicant is G & W Applied Science Laboratories. It received FDA 510(k) clearance on 1981-12-03 under 510(k) number K813249. 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 HELP-MATE?

HELP-MATE is a medical device that received FDA 510(k) clearance on 1981-12-03. The listed applicant is G & W Applied Science Laboratories. The 510(k) number is K813249.

When did HELP-MATE receive FDA 510(k) clearance?

HELP-MATE received FDA 510(k) clearance on 1981-12-03, under 510(k) number K813249.

Who is the listed applicant for HELP-MATE?

The FDA 510(k) record lists G & W Applied Science Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HELP-MATE?

The FDA product code for HELP-MATE is ESD.

Other records listing G & W Applied Science Laboratories 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.

K780805S/D 600 SPHYGMOMANOMETER AND PULSEMETERK7806774600 RECORDERK780566HEALTH SEAT SYSTEM

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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