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FDA 510(k)

ELECTROTHERM MODELS TC-100 & M-99

K-Number: K771995 · 1977-11-22

ApplicantElectromedics, Inc.
Decision Date1977-11-22
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ELECTROTHERM MODELS TC-100 & M-99 is the device name listed in this FDA 510(k) record. The listed applicant is Electromedics, Inc.. It received FDA 510(k) clearance on 1977-11-22 under 510(k) number K771995. The device is classified under product code FLL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELECTROTHERM MODELS TC-100 & M-99?

ELECTROTHERM MODELS TC-100 & M-99 is a medical device that received FDA 510(k) clearance on 1977-11-22. The listed applicant is Electromedics, Inc.. The 510(k) number is K771995.

When did ELECTROTHERM MODELS TC-100 & M-99 receive FDA 510(k) clearance?

ELECTROTHERM MODELS TC-100 & M-99 received FDA 510(k) clearance on 1977-11-22, under 510(k) number K771995.

Who is the listed applicant for ELECTROTHERM MODELS TC-100 & M-99?

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

What is the FDA product code for ELECTROTHERM MODELS TC-100 & M-99?

The FDA product code for ELECTROTHERM MODELS TC-100 & M-99 is FLL.

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Related Devices (Code: FLL)

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

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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