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FDA 510(k)

LIGHT, EXAMINATION, MEDICAL (MEL)

K-Number: K770567 · 1977-04-14

ApplicantFiber Optics Engineering, Inc.
Decision Date1977-04-14
Product CodeFTD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LIGHT, EXAMINATION, MEDICAL (MEL) is the device name listed in this FDA 510(k) record. The listed applicant is Fiber Optics Engineering, Inc.. It received FDA 510(k) clearance on 1977-04-14 under 510(k) number K770567. The device is classified under product code FTD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIGHT, EXAMINATION, MEDICAL (MEL)?

LIGHT, EXAMINATION, MEDICAL (MEL) is a medical device that received FDA 510(k) clearance on 1977-04-14. The listed applicant is Fiber Optics Engineering, Inc.. The 510(k) number is K770567.

When did LIGHT, EXAMINATION, MEDICAL (MEL) receive FDA 510(k) clearance?

LIGHT, EXAMINATION, MEDICAL (MEL) received FDA 510(k) clearance on 1977-04-14, under 510(k) number K770567.

Who is the listed applicant for LIGHT, EXAMINATION, MEDICAL (MEL)?

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

What is the FDA product code for LIGHT, EXAMINATION, MEDICAL (MEL)?

The FDA product code for LIGHT, EXAMINATION, MEDICAL (MEL) is FTD.

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 Fiber Optics Engineering, 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.

K770568SURGICAL ILLUMINATOR (SIL)

Related Devices (Code: FTD)

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.

K133425SCINTILLANT DUAL BENT TIP SURGICAL LIGHT, SCINTILLANT DUAL STRAIGHT TIP SURGICAL LIGHTEngineered Medical Solutions Co., LLCK130513VOLISTA 400; VOLISTA 600Maquet S.A.S.K123776POLARIS 100/200Drager Medical GmbHK111020ATRICURE DISSECTORAtriCure, Inc.K100234HM-LAMP IIHillusa, Inc.K100884STRYKER KNIFELIGHTHowmedica Osteonics Corp.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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