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FDA 510(k)

SOUNMED COLOPOSCOPE COLPO-99/99PLUS

K-Number: K070845 · 2007-10-12

ApplicantSounmed, Inc.
Decision Date2007-10-12
Product CodeHEX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SOUNMED COLOPOSCOPE COLPO-99/99PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Sounmed, Inc.. It received FDA 510(k) clearance on 2007-10-12 under 510(k) number K070845. 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 SOUNMED COLOPOSCOPE COLPO-99/99PLUS?

SOUNMED COLOPOSCOPE COLPO-99/99PLUS is a medical device that received FDA 510(k) clearance on 2007-10-12. The listed applicant is Sounmed, Inc.. The 510(k) number is K070845.

When did SOUNMED COLOPOSCOPE COLPO-99/99PLUS receive FDA 510(k) clearance?

SOUNMED COLOPOSCOPE COLPO-99/99PLUS received FDA 510(k) clearance on 2007-10-12, under 510(k) number K070845.

Who is the listed applicant for SOUNMED COLOPOSCOPE COLPO-99/99PLUS?

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

What is the FDA product code for SOUNMED COLOPOSCOPE COLPO-99/99PLUS?

The FDA product code for SOUNMED COLOPOSCOPE COLPO-99/99PLUS is HEX.

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 Sounmed, 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.

K071156SOUNMED SD-2000 PLUS PORTABLE ULTRASOUND SCANNER

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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