FDA 510(k)

TEVES ECM PLUS THERMOCOUPLE

K-Number: K951768 · 1995-12-15

ApplicantAdvanced Medical Concepts, Inc.

Decision Date1995-12-15

Product CodeBTR

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

TEVES ECM PLUS THERMOCOUPLE is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Medical Concepts, Inc.. It received FDA 510(k) clearance on 1995-12-15 under 510(k) number K951768. The device is classified under product code BTR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TEVES ECM PLUS THERMOCOUPLE?

TEVES ECM PLUS THERMOCOUPLE is a medical device that received FDA 510(k) clearance on 1995-12-15. The listed applicant is Advanced Medical Concepts, Inc.. The 510(k) number is K951768.

When did TEVES ECM PLUS THERMOCOUPLE receive FDA 510(k) clearance?

TEVES ECM PLUS THERMOCOUPLE received FDA 510(k) clearance on 1995-12-15, under 510(k) number K951768.

Who is the listed applicant for TEVES ECM PLUS THERMOCOUPLE?

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

What is the FDA product code for TEVES ECM PLUS THERMOCOUPLE?

The FDA product code for TEVES ECM PLUS THERMOCOUPLE is BTR.

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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.