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FDA 510(k)

SELITHERM, MODEL C100

K-Number: K030382 · 2003-04-01

ApplicantSelicor, Inc.
Decision Date2003-04-01
Product CodeIMJ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SELITHERM, MODEL C100 is the device name listed in this FDA 510(k) record. The listed applicant is Selicor, Inc.. It received FDA 510(k) clearance on 2003-04-01 under 510(k) number K030382. The device is classified under product code IMJ. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SELITHERM, MODEL C100?

SELITHERM, MODEL C100 is a medical device that received FDA 510(k) clearance on 2003-04-01. The listed applicant is Selicor, Inc.. The 510(k) number is K030382.

When did SELITHERM, MODEL C100 receive FDA 510(k) clearance?

SELITHERM, MODEL C100 received FDA 510(k) clearance on 2003-04-01, under 510(k) number K030382.

Who is the listed applicant for SELITHERM, MODEL C100?

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

What is the FDA product code for SELITHERM, MODEL C100?

The FDA product code for SELITHERM, MODEL C100 is IMJ.

Related Clinical Trials

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Other records listing Selicor, 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.

K020227SELICOR, MODELS A100 & D100

Related Devices (Code: IMJ)

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.

K252963BTL-899TTBTL Industries, Inc.K250376ViVYViatherm Therapeutics, LLCK243112Curapuls 670Enraf-Nonius, B.V.K223620Reprieve by RegenesisTMRegenesis Biomedical, Inc.K182363BTL-703BTL Industries, Inc.K173300ViaTherm BOOSTViatherm Therapeutics, LLC

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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