FDA 510(k)

NEO NEST

K-Number: K112547 · 2012-03-06

Decision Date2012-03-06

Product CodeIMD

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

NEO NEST is the device name listed in this FDA 510(k) record. The listed applicant is Denovo Proucts, LLC. It received FDA 510(k) clearance on 2012-03-06 under 510(k) number K112547. The device is classified under product code IMD. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEO NEST?

NEO NEST is a medical device that received FDA 510(k) clearance on 2012-03-06. The listed applicant is Denovo Proucts, LLC. The 510(k) number is K112547.

When did NEO NEST receive FDA 510(k) clearance?

NEO NEST received FDA 510(k) clearance on 2012-03-06, under 510(k) number K112547.

Who is the listed applicant for NEO NEST?

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

What is the FDA product code for NEO NEST?

The FDA product code for NEO NEST is IMD.

Related Devices (Code: IMD)

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.

K221653InfaTherm Disposable Infant Warming MattressInternational Biomedical K163295Infant Transport Mattress Warmer with DiscRapid Aid Corp.K082087EYEFEEL OPHTHALMIC WARMERBio-Lipid, Inc.K071710BENGAY (R) HEAT THERAPY, PAIN RELIEVING PATCHES/PADS (VARIOUS)Johnson & Johnson Consumer Products, Inc.K021843EYEFEEL OPHTHALMIC WARMERBio-Lipid, Inc.K982652ALLEGIANCE PORTA-WARM MATTRESSAllegiance Healthcare Corp.

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.