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FDA 510(k)

PHILIPS S1594 OTB HEARING AID

K-Number: K913389 · 1991-08-26

ApplicantPhilips Hearing Instruments Co.
Decision Date1991-08-26
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

PHILIPS S1594 OTB HEARING AID is the device name listed in this FDA 510(k) record. The listed applicant is Philips Hearing Instruments Co.. It received FDA 510(k) clearance on 1991-08-26 under 510(k) number K913389. 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 PHILIPS S1594 OTB HEARING AID?

PHILIPS S1594 OTB HEARING AID is a medical device that received FDA 510(k) clearance on 1991-08-26. The listed applicant is Philips Hearing Instruments Co.. The 510(k) number is K913389.

When did PHILIPS S1594 OTB HEARING AID receive FDA 510(k) clearance?

PHILIPS S1594 OTB HEARING AID received FDA 510(k) clearance on 1991-08-26, under 510(k) number K913389.

Who is the listed applicant for PHILIPS S1594 OTB HEARING AID?

The FDA 510(k) record lists Philips Hearing Instruments Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PHILIPS S1594 OTB HEARING AID?

The FDA product code for PHILIPS S1594 OTB HEARING AID is ESD.

Related Clinical Trials

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Other records listing Philips Hearing Instruments Co. 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.

K972818D72 DIGITALK971804PHILIPS S1694, S1695K965088M11 SERIES: M11, M11MK961770PHILIPS 71 SERIESK952658HEARING AIDK944404MO4 SERIES

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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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