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FDA 510(k)

SHAKE-N-WARM

K-Number: K770505 · 1977-04-05

ApplicantSignal West
Decision Date1977-04-05
Product CodeIMD
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SHAKE-N-WARM is the device name listed in this FDA 510(k) record. The listed applicant is Signal West. It received FDA 510(k) clearance on 1977-04-05 under 510(k) number K770505. 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 SHAKE-N-WARM?

SHAKE-N-WARM is a medical device that received FDA 510(k) clearance on 1977-04-05. The listed applicant is Signal West. The 510(k) number is K770505.

When did SHAKE-N-WARM receive FDA 510(k) clearance?

SHAKE-N-WARM received FDA 510(k) clearance on 1977-04-05, under 510(k) number K770505.

Who is the listed applicant for SHAKE-N-WARM?

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

What is the FDA product code for SHAKE-N-WARM?

The FDA product code for SHAKE-N-WARM 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.

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Other records listing Signal West 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.

K802252HOT CYCLE, A CHEMICAL TYPE HOT PACKK780014COLD CYCLE, CHEMICAL COLD PACK

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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