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FDA 510(k)

PERFECT EAR PE/PE-AGC/PE-B/PE-PWR

K-Number: K960410 · 1996-04-04

ApplicantPerfect Ear
Decision Date1996-04-04
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

PERFECT EAR PE/PE-AGC/PE-B/PE-PWR is the device name listed in this FDA 510(k) record. The listed applicant is Perfect Ear. It received FDA 510(k) clearance on 1996-04-04 under 510(k) number K960410. 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 PERFECT EAR PE/PE-AGC/PE-B/PE-PWR?

PERFECT EAR PE/PE-AGC/PE-B/PE-PWR is a medical device that received FDA 510(k) clearance on 1996-04-04. The listed applicant is Perfect Ear. The 510(k) number is K960410.

When did PERFECT EAR PE/PE-AGC/PE-B/PE-PWR receive FDA 510(k) clearance?

PERFECT EAR PE/PE-AGC/PE-B/PE-PWR received FDA 510(k) clearance on 1996-04-04, under 510(k) number K960410.

Who is the listed applicant for PERFECT EAR PE/PE-AGC/PE-B/PE-PWR?

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

What is the FDA product code for PERFECT EAR PE/PE-AGC/PE-B/PE-PWR?

The FDA product code for PERFECT EAR PE/PE-AGC/PE-B/PE-PWR is ESD.

Related Clinical Trials

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.

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Other records listing Perfect Ear 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.

K973972PERFECT EAR/ MINI-CANAL/ PE-M, PE-ML, PE-MD), PERFECT EAR/ C.I.C./ (PEC, PE-CD) (WITH OR WITHOUT RID-WAX BARRIER)K931984PERFECT EAR/PE

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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