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FDA 510(k)

MEDISCOPE

K-Number: K031436 · 2003-12-19

ApplicantSometech Corporation
Decision Date2003-12-19
Product CodeHEX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MEDISCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Sometech Corporation. It received FDA 510(k) clearance on 2003-12-19 under 510(k) number K031436. 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 MEDISCOPE?

MEDISCOPE is a medical device that received FDA 510(k) clearance on 2003-12-19. The listed applicant is Sometech Corporation. The 510(k) number is K031436.

When did MEDISCOPE receive FDA 510(k) clearance?

MEDISCOPE received FDA 510(k) clearance on 2003-12-19, under 510(k) number K031436.

Who is the listed applicant for MEDISCOPE?

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

What is the FDA product code for MEDISCOPE?

The FDA product code for MEDISCOPE is HEX.

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Other records listing Sometech Corporation 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.

K121401TENDER TOUCHK024186X-VIEW

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

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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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