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FDA 510(k)

CONCEIVE PLUS

K-Number: K131355 · 2013-11-07

ApplicantSasmar, Inc.
Decision Date2013-11-07
Product CodePEB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

CONCEIVE PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Sasmar, Inc.. It received FDA 510(k) clearance on 2013-11-07 under 510(k) number K131355. The device is classified under product code PEB. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CONCEIVE PLUS?

CONCEIVE PLUS is a medical device that received FDA 510(k) clearance on 2013-11-07. The listed applicant is Sasmar, Inc.. The 510(k) number is K131355.

When did CONCEIVE PLUS receive FDA 510(k) clearance?

CONCEIVE PLUS received FDA 510(k) clearance on 2013-11-07, under 510(k) number K131355.

Who is the listed applicant for CONCEIVE PLUS?

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

What is the FDA product code for CONCEIVE PLUS?

The FDA product code for CONCEIVE PLUS is PEB.

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 Sasmar, 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.

K131084SASMAR ORIGINAL, SASMAR CLASSIC

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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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