FDA 510(k)

STAT-PAD

K-Number: K894926 · 1989-09-05

Decision Date1989-09-05

Product CodeIMD

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

STAT-PAD is the device name listed in this FDA 510(k) record. The listed applicant is Hettel Accessories, Inc.. It received FDA 510(k) clearance on 1989-09-05 under 510(k) number K894926. 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 STAT-PAD?

STAT-PAD is a medical device that received FDA 510(k) clearance on 1989-09-05. The listed applicant is Hettel Accessories, Inc.. The 510(k) number is K894926.

When did STAT-PAD receive FDA 510(k) clearance?

STAT-PAD received FDA 510(k) clearance on 1989-09-05, under 510(k) number K894926.

Who is the listed applicant for STAT-PAD?

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

What is the FDA product code for STAT-PAD?

The FDA product code for STAT-PAD 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.K112547NEO NESTDenovo Proucts, LLC K082087EYEFEEL OPHTHALMIC WARMERBio-Lipid, Inc.K071710BENGAY (R) HEAT THERAPY, PAIN RELIEVING PATCHES/PADS (VARIOUS)Johnson & Johnson Consumer Products, Inc.K021843EYEFEEL OPHTHALMIC WARMERBio-Lipid, Inc.

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.