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FDA 510(k)

XOMED-TREACE ALPHASCOPE

K-Number: K923830 · 1992-11-09

ApplicantXomed-Treace, Inc.
Decision Date1992-11-09
Product CodeERA
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

XOMED-TREACE ALPHASCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Xomed-Treace, Inc.. It received FDA 510(k) clearance on 1992-11-09 under 510(k) number K923830. The device is classified under product code ERA. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XOMED-TREACE ALPHASCOPE?

XOMED-TREACE ALPHASCOPE is a medical device that received FDA 510(k) clearance on 1992-11-09. The listed applicant is Xomed-Treace, Inc.. The 510(k) number is K923830.

When did XOMED-TREACE ALPHASCOPE receive FDA 510(k) clearance?

XOMED-TREACE ALPHASCOPE received FDA 510(k) clearance on 1992-11-09, under 510(k) number K923830.

Who is the listed applicant for XOMED-TREACE ALPHASCOPE?

The FDA 510(k) record lists Xomed-Treace, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for XOMED-TREACE ALPHASCOPE?

The FDA product code for XOMED-TREACE ALPHASCOPE is ERA.

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 Xomed-Treace, 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.

K940028ENDOSCOPE SHEATHK941407TYMPANOSTOMY (VENTILATION) TUBEK945659BLACKSTAR(TM) STAR SYSTEMK932771BATTERY POWERED, DISPOSABLE ENDOSCOPE LIGHT SOURCEK933672XOMED-TREACE SCOPESHEATHK934426NERVE INTEGRITY MONITOR-2 (NIM-2 XL)

View all 12 devices →

Related Devices (Code: ERA)

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.

K123821AIO HD OTOSCOPEBlue FocusK121326LANTOS 3D EAR SCANNERLantos TechnologiesK110326OSRAM ITOSOsram Sylvania, Inc.K945264OPTUS OTOSCOPESOptus, Inc.K955043WELCH ALLYN BI-OTOSCOPEWelch Allyn, Inc.K952578WELCH ALLY OTOSCOPEWelch Allyn, 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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