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FDA 510(k)

SYSTEM 80 FACEPLATE-IN-THE-EAR #F1

K-Number: K822411 · 1983-07-12

ApplicantWestern Advanced Technology, Inc.
Decision Date1983-07-12
Product CodeEIB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SYSTEM 80 FACEPLATE-IN-THE-EAR #F1 is the device name listed in this FDA 510(k) record. The listed applicant is Western Advanced Technology, Inc.. It received FDA 510(k) clearance on 1983-07-12 under 510(k) number K822411. The device is classified under product code EIB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYSTEM 80 FACEPLATE-IN-THE-EAR #F1?

SYSTEM 80 FACEPLATE-IN-THE-EAR #F1 is a medical device that received FDA 510(k) clearance on 1983-07-12. The listed applicant is Western Advanced Technology, Inc.. The 510(k) number is K822411.

When did SYSTEM 80 FACEPLATE-IN-THE-EAR #F1 receive FDA 510(k) clearance?

SYSTEM 80 FACEPLATE-IN-THE-EAR #F1 received FDA 510(k) clearance on 1983-07-12, under 510(k) number K822411.

Who is the listed applicant for SYSTEM 80 FACEPLATE-IN-THE-EAR #F1?

The FDA 510(k) record lists Western Advanced Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SYSTEM 80 FACEPLATE-IN-THE-EAR #F1?

The FDA product code for SYSTEM 80 FACEPLATE-IN-THE-EAR #F1 is EIB.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Western Advanced Technology, Inc. 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.

K813557AUDITORY STIMULATORK812138TENS DEVICEK811790OCTOTOXIC SCREENERK811772AUDITORY LOCALIZERK802324E1 SERIES HEARING AID

Related Devices (Code: EIB)

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.

K911118DTF-1000LL,DTF-1000Cp MedicalK874543MODEL OPO-32 IRRIGATION SLEEVEAllergan, Inc.K760570ROBINSON MIDDLE EAR PROSTHESISXomed, 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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