FDA 510(k)

STATSTRAP NEONATAL INCUBATOR SAFETY STRAP, MODELS SS-001, SS-002

K-Number: K081264 · 2009-02-13

Decision Date2009-02-13

Product CodeFMQ

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

STATSTRAP NEONATAL INCUBATOR SAFETY STRAP, MODELS SS-001, SS-002 is the device name listed in this FDA 510(k) record. The listed applicant is Children'S Health First, Inc.. It received FDA 510(k) clearance on 2009-02-13 under 510(k) number K081264. The device is classified under product code FMQ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STATSTRAP NEONATAL INCUBATOR SAFETY STRAP, MODELS SS-001, SS-002?

STATSTRAP NEONATAL INCUBATOR SAFETY STRAP, MODELS SS-001, SS-002 is a medical device that received FDA 510(k) clearance on 2009-02-13. The listed applicant is Children'S Health First, Inc.. The 510(k) number is K081264.

When did STATSTRAP NEONATAL INCUBATOR SAFETY STRAP, MODELS SS-001, SS-002 receive FDA 510(k) clearance?

STATSTRAP NEONATAL INCUBATOR SAFETY STRAP, MODELS SS-001, SS-002 received FDA 510(k) clearance on 2009-02-13, under 510(k) number K081264.

Who is the listed applicant for STATSTRAP NEONATAL INCUBATOR SAFETY STRAP, MODELS SS-001, SS-002?

The FDA 510(k) record lists Children'S Health First, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STATSTRAP NEONATAL INCUBATOR SAFETY STRAP, MODELS SS-001, SS-002?

The FDA product code for STATSTRAP NEONATAL INCUBATOR SAFETY STRAP, MODELS SS-001, SS-002 is FMQ.

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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.