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FDA 510(k)

BATTERY POWERED, DISPOSABLE ENDOSCOPE LIGHT SOURCE

K-Number: K932771 · 1994-08-24

ApplicantXomed-Treace, Inc.
Decision Date1994-08-24
Product CodeEQH
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

BATTERY POWERED, DISPOSABLE ENDOSCOPE LIGHT SOURCE 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 1994-08-24 under 510(k) number K932771. The device is classified under product code EQH. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BATTERY POWERED, DISPOSABLE ENDOSCOPE LIGHT SOURCE?

BATTERY POWERED, DISPOSABLE ENDOSCOPE LIGHT SOURCE is a medical device that received FDA 510(k) clearance on 1994-08-24. The listed applicant is Xomed-Treace, Inc.. The 510(k) number is K932771.

When did BATTERY POWERED, DISPOSABLE ENDOSCOPE LIGHT SOURCE receive FDA 510(k) clearance?

BATTERY POWERED, DISPOSABLE ENDOSCOPE LIGHT SOURCE received FDA 510(k) clearance on 1994-08-24, under 510(k) number K932771.

Who is the listed applicant for BATTERY POWERED, DISPOSABLE ENDOSCOPE LIGHT SOURCE?

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 BATTERY POWERED, DISPOSABLE ENDOSCOPE LIGHT SOURCE?

The FDA product code for BATTERY POWERED, DISPOSABLE ENDOSCOPE LIGHT SOURCE is EQH.

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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 SYSTEMK933672XOMED-TREACE SCOPESHEATHK934426NERVE INTEGRITY MONITOR-2 (NIM-2 XL)K933105XOMED-TREACE RIGID ROD LENS ENDOSCOPE

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Related Devices (Code: EQH)

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.

K945876WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHTWells Johnson Co.K954184JED-LIGHT FIBEROPTIC LIGHT SOURCEJedmed Instrument Co.K951829COLD LIGHT SOURCE LOS 150Laser-Optik-Systeme GmbH & Co. KGK941661GM OPTI*CAM CAMER WITH DENTAL FIBER OPTIC LIGHTGm Engineering, Inc.K941662GM OPTI*CAM CAMERA WITH ENT FIBER OPTIC LIGHTGm Engineering, Inc.K934911SAPHIRE PLUS SURGICAL MIRRORSan Diego Swiss Machining, 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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