FDA 510(k)

MEDI-PACK

K-Number: K895860 · 1990-01-02

Decision Date1990-01-02

Product CodeIMD

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

MEDI-PACK is the device name listed in this FDA 510(k) record. The listed applicant is Heatmax Mfg., Inc.. It received FDA 510(k) clearance on 1990-01-02 under 510(k) number K895860. 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 MEDI-PACK?

MEDI-PACK is a medical device that received FDA 510(k) clearance on 1990-01-02. The listed applicant is Heatmax Mfg., Inc.. The 510(k) number is K895860.

When did MEDI-PACK receive FDA 510(k) clearance?

MEDI-PACK received FDA 510(k) clearance on 1990-01-02, under 510(k) number K895860.

Who is the listed applicant for MEDI-PACK?

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

What is the FDA product code for MEDI-PACK?

The FDA product code for MEDI-PACK 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.