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FDA 510(k)

TULANE HEAT-PACK

K-Number: K790480 · 1979-04-03

ApplicantTulane
Decision Date1979-04-03
Product CodeIMD
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

TULANE HEAT-PACK is the device name listed in this FDA 510(k) record. The listed applicant is Tulane. It received FDA 510(k) clearance on 1979-04-03 under 510(k) number K790480. 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 TULANE HEAT-PACK?

TULANE HEAT-PACK is a medical device that received FDA 510(k) clearance on 1979-04-03. The listed applicant is Tulane. The 510(k) number is K790480.

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

TULANE HEAT-PACK received FDA 510(k) clearance on 1979-04-03, under 510(k) number K790480.

Who is the listed applicant for TULANE HEAT-PACK?

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

What is the FDA product code for TULANE HEAT-PACK?

The FDA product code for TULANE HEAT-PACK is IMD.

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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 BiomedicalK163295Infant Transport Mattress Warmer with DiscRapid Aid Corp.K112547NEO NESTDenovo Proucts, LLCK082087EYEFEEL 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

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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