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FDA 510(k)

CERVILENZ UTERINE MEASURING SOUND

K-Number: K011840 · 2001-08-10

ApplicantCervilenz, Inc.
Decision Date2001-08-10
Product CodeHHM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

CERVILENZ UTERINE MEASURING SOUND is the device name listed in this FDA 510(k) record. The listed applicant is Cervilenz, Inc.. It received FDA 510(k) clearance on 2001-08-10 under 510(k) number K011840. The device is classified under product code HHM. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CERVILENZ UTERINE MEASURING SOUND?

CERVILENZ UTERINE MEASURING SOUND is a medical device that received FDA 510(k) clearance on 2001-08-10. The listed applicant is Cervilenz, Inc.. The 510(k) number is K011840.

When did CERVILENZ UTERINE MEASURING SOUND receive FDA 510(k) clearance?

CERVILENZ UTERINE MEASURING SOUND received FDA 510(k) clearance on 2001-08-10, under 510(k) number K011840.

Who is the listed applicant for CERVILENZ UTERINE MEASURING SOUND?

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

What is the FDA product code for CERVILENZ UTERINE MEASURING SOUND?

The FDA product code for CERVILENZ UTERINE MEASURING SOUND is HHM.

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Related Devices (Code: HHM)

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.

K935665INTRAUTERINE SOUNDRocket of London, Ltd.K884684ROCKET INTRAUTERINE DEPTH SOUNDA & A Medical, Inc.K883806ROCKET INTRAUTERINE SOUNDA & A Medical, Inc.K870550TEFLON UTERINE SOUNDCook Ob/GynK840380UTERINE SOUNDIntl. Medical Technologies, Inc.K831224AUGROS HYSTEROMETERAxcan Scientific 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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