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FDA 510(k)

SENSE-4BABY SYSTEM

K-Number: K132918 · 2013-11-22

ApplicantSense4baby , Inc.
Decision Date2013-11-22
Product CodeHGM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SENSE-4BABY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Sense4baby , Inc.. It received FDA 510(k) clearance on 2013-11-22 under 510(k) number K132918. The device is classified under product code HGM. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SENSE-4BABY SYSTEM?

SENSE-4BABY SYSTEM is a medical device that received FDA 510(k) clearance on 2013-11-22. The listed applicant is Sense4baby , Inc.. The 510(k) number is K132918.

When did SENSE-4BABY SYSTEM receive FDA 510(k) clearance?

SENSE-4BABY SYSTEM received FDA 510(k) clearance on 2013-11-22, under 510(k) number K132918.

Who is the listed applicant for SENSE-4BABY SYSTEM?

The FDA 510(k) record lists Sense4baby , Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SENSE-4BABY SYSTEM?

The FDA product code for SENSE-4BABY SYSTEM is HGM.

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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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