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FDA 510(k)

KRYMED SYSTEM 4001 TILT SCOPE

K-Number: K801730 · 1980-08-13

ApplicantCryomedics, Inc.
Decision Date1980-08-13
Product CodeHEX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

KRYMED SYSTEM 4001 TILT SCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Cryomedics, Inc.. It received FDA 510(k) clearance on 1980-08-13 under 510(k) number K801730. The device is classified under product code HEX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KRYMED SYSTEM 4001 TILT SCOPE?

KRYMED SYSTEM 4001 TILT SCOPE is a medical device that received FDA 510(k) clearance on 1980-08-13. The listed applicant is Cryomedics, Inc.. The 510(k) number is K801730.

When did KRYMED SYSTEM 4001 TILT SCOPE receive FDA 510(k) clearance?

KRYMED SYSTEM 4001 TILT SCOPE received FDA 510(k) clearance on 1980-08-13, under 510(k) number K801730.

Who is the listed applicant for KRYMED SYSTEM 4001 TILT SCOPE?

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

What is the FDA product code for KRYMED SYSTEM 4001 TILT SCOPE?

The FDA product code for KRYMED SYSTEM 4001 TILT SCOPE is HEX.

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Other records listing Cryomedics, Inc. as applicant

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Related Devices (Code: HEX)

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.

K233043Smart Scope® CXPeriwinkle Technologies Pvt., Ltd.K190187Gynescope SystemIllumigyn , Ltd.K182764Biop Digital ColposcopeBiop Medical , Ltd.K181034Pocket Colposcope SystemHadleigh Health Technologies, LLCK170446LT-300 SD Digital Video ColposcopeLutech Industries, Inc.K161871EVA (Enhanced Visual Assessment) SystemMobileodt , Ltd.

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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