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FDA 510(k)

CERTI HEAT INSTANT HEAT COMPRESS

K-Number: K940336 · 1994-03-07

ApplicantCertified Safety Mfg., Inc.
Decision Date1994-03-07
Product CodeIMD
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

CERTI HEAT INSTANT HEAT COMPRESS is the device name listed in this FDA 510(k) record. The listed applicant is Certified Safety Mfg., Inc.. It received FDA 510(k) clearance on 1994-03-07 under 510(k) number K940336. 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 CERTI HEAT INSTANT HEAT COMPRESS?

CERTI HEAT INSTANT HEAT COMPRESS is a medical device that received FDA 510(k) clearance on 1994-03-07. The listed applicant is Certified Safety Mfg., Inc.. The 510(k) number is K940336.

When did CERTI HEAT INSTANT HEAT COMPRESS receive FDA 510(k) clearance?

CERTI HEAT INSTANT HEAT COMPRESS received FDA 510(k) clearance on 1994-03-07, under 510(k) number K940336.

Who is the listed applicant for CERTI HEAT INSTANT HEAT COMPRESS?

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

What is the FDA product code for CERTI HEAT INSTANT HEAT COMPRESS?

The FDA product code for CERTI HEAT INSTANT HEAT COMPRESS is IMD.

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Other records listing Certified Safety Mfg., 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.

K960587CPROTECTOR 2000K960615GAUZE COMPRESSK960624CERTI COOL INSTANT COLD COMPRESSK953102BLOODBORNE PATHOGEN KITK946338CERTIBURN BURN/TRAUMA FACE DRESSING, TOWEL DRESSINGK9450042, 3 & 4 BANDADGE COMPRESS

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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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