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FDA 510(k)

FOCUS TOUCH CONCEPTION SYSTEM

K-Number: K112200 · 2012-09-06

Decision Date2012-09-06
Product CodeOBB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

FOCUS TOUCH CONCEPTION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Intimate Bridge 2 Conception, Inc.. It received FDA 510(k) clearance on 2012-09-06 under 510(k) number K112200. The device is classified under product code OBB. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FOCUS TOUCH CONCEPTION SYSTEM?

FOCUS TOUCH CONCEPTION SYSTEM is a medical device that received FDA 510(k) clearance on 2012-09-06. The listed applicant is Intimate Bridge 2 Conception, Inc.. The 510(k) number is K112200.

When did FOCUS TOUCH CONCEPTION SYSTEM receive FDA 510(k) clearance?

FOCUS TOUCH CONCEPTION SYSTEM received FDA 510(k) clearance on 2012-09-06, under 510(k) number K112200.

Who is the listed applicant for FOCUS TOUCH CONCEPTION SYSTEM?

The FDA 510(k) record lists Intimate Bridge 2 Conception, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FOCUS TOUCH CONCEPTION SYSTEM?

The FDA product code for FOCUS TOUCH CONCEPTION SYSTEM is OBB.

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.

Related Devices (Code: OBB)

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.

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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