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FDA 510(k)

AUTO*THERM 395, MODEL ME 395

K-Number: K022458 · 2002-09-26

ApplicantMettler Electronics Corp.
Decision Date2002-09-26
Product CodeIMJ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

AUTO*THERM 395, MODEL ME 395 is the device name listed in this FDA 510(k) record. The listed applicant is Mettler Electronics Corp.. It received FDA 510(k) clearance on 2002-09-26 under 510(k) number K022458. 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 AUTO*THERM 395, MODEL ME 395?

AUTO*THERM 395, MODEL ME 395 is a medical device that received FDA 510(k) clearance on 2002-09-26. The listed applicant is Mettler Electronics Corp.. The 510(k) number is K022458.

When did AUTO*THERM 395, MODEL ME 395 receive FDA 510(k) clearance?

AUTO*THERM 395, MODEL ME 395 received FDA 510(k) clearance on 2002-09-26, under 510(k) number K022458.

Who is the listed applicant for AUTO*THERM 395, MODEL ME 395?

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

What is the FDA product code for AUTO*THERM 395, MODEL ME 395?

The FDA product code for AUTO*THERM 395, MODEL ME 395 is IMJ.

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Other records listing Mettler Electronics Corp. 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.

K113017SYS*STIM 240K111482SONICATOR PLUS 920K091540MTD 4000K071137SONICATOR PLUS 940, MODEL ME940K053546SONICATOR 740, MODEL ME 740K043586LASER SYS*STIM 540, MODEL ME 540

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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

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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