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FDA 510(k)

FIBER OPTIC ADAPTER #60-0897

K-Number: K802768 · 1980-12-16

ApplicantAspen Laboratories, Inc.
Decision Date1980-12-16
Product CodeEQH
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

FIBER OPTIC ADAPTER #60-0897 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 1980-12-16 under 510(k) number K802768. 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 ADAPTER #60-0897?

FIBER OPTIC ADAPTER #60-0897 is a medical device that received FDA 510(k) clearance on 1980-12-16. The listed applicant is Aspen Laboratories, Inc.. The 510(k) number is K802768.

When did FIBER OPTIC ADAPTER #60-0897 receive FDA 510(k) clearance?

FIBER OPTIC ADAPTER #60-0897 received FDA 510(k) clearance on 1980-12-16, under 510(k) number K802768.

Who is the listed applicant for FIBER OPTIC ADAPTER #60-0897?

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 ADAPTER #60-0897?

The FDA product code for FIBER OPTIC ADAPTER #60-0897 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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