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FDA 510(k)

EYEFEEL OPHTHALMIC WARMER

K-Number: K021843 · 2002-09-03

ApplicantBio-Lipid, Inc.
Decision Date2002-09-03
Product CodeIMD
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

EYEFEEL OPHTHALMIC WARMER is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Lipid, Inc.. It received FDA 510(k) clearance on 2002-09-03 under 510(k) number K021843. 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 EYEFEEL OPHTHALMIC WARMER?

EYEFEEL OPHTHALMIC WARMER is a medical device that received FDA 510(k) clearance on 2002-09-03. The listed applicant is Bio-Lipid, Inc.. The 510(k) number is K021843.

When did EYEFEEL OPHTHALMIC WARMER receive FDA 510(k) clearance?

EYEFEEL OPHTHALMIC WARMER received FDA 510(k) clearance on 2002-09-03, under 510(k) number K021843.

Who is the listed applicant for EYEFEEL OPHTHALMIC WARMER?

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

What is the FDA product code for EYEFEEL OPHTHALMIC WARMER?

The FDA product code for EYEFEEL OPHTHALMIC WARMER 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 Bio-Lipid, 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.

K082087EYEFEEL OPHTHALMIC WARMER

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.K982652ALLEGIANCE PORTA-WARM MATTRESSAllegiance Healthcare Corp.

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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