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FDA 510(k)

TEMPRA COLD PACK, REORDER NO. TC150

K-Number: K963220 · 1996-10-10

ApplicantTempo Technology, Inc.
Decision Date1996-10-10
Product CodeIMD
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

TEMPRA COLD PACK, REORDER NO. TC150 is the device name listed in this FDA 510(k) record. The listed applicant is Tempo Technology, Inc.. It received FDA 510(k) clearance on 1996-10-10 under 510(k) number K963220. 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 TEMPRA COLD PACK, REORDER NO. TC150?

TEMPRA COLD PACK, REORDER NO. TC150 is a medical device that received FDA 510(k) clearance on 1996-10-10. The listed applicant is Tempo Technology, Inc.. The 510(k) number is K963220.

When did TEMPRA COLD PACK, REORDER NO. TC150 receive FDA 510(k) clearance?

TEMPRA COLD PACK, REORDER NO. TC150 received FDA 510(k) clearance on 1996-10-10, under 510(k) number K963220.

Who is the listed applicant for TEMPRA COLD PACK, REORDER NO. TC150?

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

What is the FDA product code for TEMPRA COLD PACK, REORDER NO. TC150?

The FDA product code for TEMPRA COLD PACK, REORDER NO. TC150 is IMD.

Related Clinical Trials

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Other records listing Tempo Technology, Inc. as applicant

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.

K934700MODEL 90P PORTABLE MEDICAL DIAGNOSTIC X-RAYK896963TRIMODE SP DENTAL INTRA ORAL X-RAY

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

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

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