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FDA 510(k)

ISOCOMFORTER

K-Number: K936143 · 1994-07-12

ApplicantIsocomforter, Inc.
Decision Date1994-07-12
Product CodeILO
Advisory CommitteePM
DecisionSubstantially Equivalent for Some Indications

Device Summary

ISOCOMFORTER is the device name listed in this FDA 510(k) record. The listed applicant is Isocomforter, Inc.. It received FDA 510(k) clearance on 1994-07-12 under 510(k) number K936143. The device is classified under product code ILO. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the ISOCOMFORTER?

ISOCOMFORTER is a medical device that received FDA 510(k) clearance on 1994-07-12. The listed applicant is Isocomforter, Inc.. The 510(k) number is K936143.

When did ISOCOMFORTER receive FDA 510(k) clearance?

ISOCOMFORTER received FDA 510(k) clearance on 1994-07-12, under 510(k) number K936143.

Who is the listed applicant for ISOCOMFORTER?

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

What is the FDA product code for ISOCOMFORTER?

The FDA product code for ISOCOMFORTER is ILO.

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Related Devices (Code: ILO)

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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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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