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FDA 510(k)

BELLECUP

K-Number: K092985 · 2010-06-28

ApplicantLibrette, Inc.
Decision Date2010-06-28
Product CodeHHE
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

BELLECUP is the device name listed in this FDA 510(k) record. The listed applicant is Librette, Inc.. It received FDA 510(k) clearance on 2010-06-28 under 510(k) number K092985. The device is classified under product code HHE. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BELLECUP?

BELLECUP is a medical device that received FDA 510(k) clearance on 2010-06-28. The listed applicant is Librette, Inc.. The 510(k) number is K092985.

When did BELLECUP receive FDA 510(k) clearance?

BELLECUP received FDA 510(k) clearance on 2010-06-28, under 510(k) number K092985.

Who is the listed applicant for BELLECUP?

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

What is the FDA product code for BELLECUP?

The FDA product code for BELLECUP is HHE.

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Related Devices (Code: HHE)

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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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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