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FDA 510(k)

FEMEYE TWO

K-Number: K093218 · 2010-05-18

ApplicantFem Suite, LLC
Decision Date2010-05-18
Product CodeHIH
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

FEMEYE TWO is the device name listed in this FDA 510(k) record. The listed applicant is Fem Suite, LLC. It received FDA 510(k) clearance on 2010-05-18 under 510(k) number K093218. The device is classified under product code HIH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FEMEYE TWO?

FEMEYE TWO is a medical device that received FDA 510(k) clearance on 2010-05-18. The listed applicant is Fem Suite, LLC. The 510(k) number is K093218.

When did FEMEYE TWO receive FDA 510(k) clearance?

FEMEYE TWO received FDA 510(k) clearance on 2010-05-18, under 510(k) number K093218.

Who is the listed applicant for FEMEYE TWO?

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

What is the FDA product code for FEMEYE TWO?

The FDA product code for FEMEYE TWO is HIH.

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Other records listing Fem Suite, LLC 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.

K062563FEMTEN CERVICAL TENACULUM

Related Devices (Code: HIH)

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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