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FDA 510(k)

IMNI HOT PACKS

K-Number: K955788 · 1996-09-04

ApplicantOmni Therm, Inc.
Decision Date1996-09-04
Product CodeIMD
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

IMNI HOT PACKS is the device name listed in this FDA 510(k) record. The listed applicant is Omni Therm, Inc.. It received FDA 510(k) clearance on 1996-09-04 under 510(k) number K955788. 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 IMNI HOT PACKS?

IMNI HOT PACKS is a medical device that received FDA 510(k) clearance on 1996-09-04. The listed applicant is Omni Therm, Inc.. The 510(k) number is K955788.

When did IMNI HOT PACKS receive FDA 510(k) clearance?

IMNI HOT PACKS received FDA 510(k) clearance on 1996-09-04, under 510(k) number K955788.

Who is the listed applicant for IMNI HOT PACKS?

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

What is the FDA product code for IMNI HOT PACKS?

The FDA product code for IMNI HOT PACKS is IMD.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Omni Therm, 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.

K961176OMNI COLD GEL PACKSK954877OMNI COLD GEL PACKSK936084OMNI WARM GEL PACKSK864853OMNI THERM TEMPERATURE MONITOR

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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