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FDA 510(k)

LITTLE ANGELS SWADDLING BLANKET

K-Number: K123411 · 2013-03-07

ApplicantBionix Development Corp.
Decision Date2013-03-07
Product CodePDH
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

LITTLE ANGELS SWADDLING BLANKET is the device name listed in this FDA 510(k) record. The listed applicant is Bionix Development Corp.. It received FDA 510(k) clearance on 2013-03-07 under 510(k) number K123411. The device is classified under product code PDH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LITTLE ANGELS SWADDLING BLANKET?

LITTLE ANGELS SWADDLING BLANKET is a medical device that received FDA 510(k) clearance on 2013-03-07. The listed applicant is Bionix Development Corp.. The 510(k) number is K123411.

When did LITTLE ANGELS SWADDLING BLANKET receive FDA 510(k) clearance?

LITTLE ANGELS SWADDLING BLANKET received FDA 510(k) clearance on 2013-03-07, under 510(k) number K123411.

Who is the listed applicant for LITTLE ANGELS SWADDLING BLANKET?

The FDA 510(k) record lists Bionix Development Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LITTLE ANGELS SWADDLING BLANKET?

The FDA product code for LITTLE ANGELS SWADDLING BLANKET is PDH.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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