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FDA 510(k)

FIBER OPTIC LIGHT SOURCE

K-Number: K801176 · 1980-05-28

ApplicantAspen Laboratories, Inc.
Decision Date1980-05-28
Product CodeEQH
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

FIBER OPTIC LIGHT SOURCE is the device name listed in this FDA 510(k) record. The listed applicant is Aspen Laboratories, Inc.. It received FDA 510(k) clearance on 1980-05-28 under 510(k) number K801176. 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 FIBER OPTIC LIGHT SOURCE?

FIBER OPTIC LIGHT SOURCE is a medical device that received FDA 510(k) clearance on 1980-05-28. The listed applicant is Aspen Laboratories, Inc.. The 510(k) number is K801176.

When did FIBER OPTIC LIGHT SOURCE receive FDA 510(k) clearance?

FIBER OPTIC LIGHT SOURCE received FDA 510(k) clearance on 1980-05-28, under 510(k) number K801176.

Who is the listed applicant for FIBER OPTIC LIGHT SOURCE?

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

What is the FDA product code for FIBER OPTIC LIGHT SOURCE?

The FDA product code for FIBER OPTIC LIGHT SOURCE is EQH.

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Other records listing Aspen Laboratories, Inc. as applicant

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K981220SYSTEM 7500 ABC ELECTROSURGICAL UNITK963088SHEATH, ELECTROSURGICAL PENCILK955834SYSTEM 6500 ABC ELECTROSURGICAL UNITK9602964000 ETMK953081BEAMER PLUSK953007EXCALIBUR PLUS ELECTROSURGICAL UNIT

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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. KGK932771BATTERY POWERED, DISPOSABLE ENDOSCOPE LIGHT SOURCEXomed-Treace, Inc.K941661GM OPTI*CAM CAMER WITH DENTAL FIBER OPTIC LIGHTGm Engineering, Inc.K941662GM OPTI*CAM CAMERA WITH ENT FIBER OPTIC LIGHTGm Engineering, 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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