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FDA 510(k)

FRITCH OPHTHALMIC ENDOSCOPE

K-Number: K855151 · 1986-02-19

ApplicantRegtec
Decision Date1986-02-19
Product CodeGDB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FRITCH OPHTHALMIC ENDOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Regtec. It received FDA 510(k) clearance on 1986-02-19 under 510(k) number K855151. The device is classified under product code GDB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FRITCH OPHTHALMIC ENDOSCOPE?

FRITCH OPHTHALMIC ENDOSCOPE is a medical device that received FDA 510(k) clearance on 1986-02-19. The listed applicant is Regtec. The 510(k) number is K855151.

When did FRITCH OPHTHALMIC ENDOSCOPE receive FDA 510(k) clearance?

FRITCH OPHTHALMIC ENDOSCOPE received FDA 510(k) clearance on 1986-02-19, under 510(k) number K855151.

Who is the listed applicant for FRITCH OPHTHALMIC ENDOSCOPE?

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

What is the FDA product code for FRITCH OPHTHALMIC ENDOSCOPE?

The FDA product code for FRITCH OPHTHALMIC ENDOSCOPE is GDB.

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Related Devices (Code: GDB)

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.

K032283DESIGNS FOR VISION FIBEROPTIC LIGHTDesigns For Vision, Inc.K961536FLEXSCOPEMatrix Medica, Inc.K935818ENDOSCOPECuda Products Co.K882061OLYMPUS GF-UM3/EU-M3Olympus Corp.K843900FOCUSCOPE UNIVERSAL SYSTEMMedical Diagnostics, Ca.K810007PENTAX UPPER G.I. FIBERSCOPE, #FG-34Pentax Precision Instrument Corp.

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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