FDA 510(k)

ME20 TRACERITE CLEAR VENT TAPE, ME30 TRACERITE NON

K-Number: K844856 · 1985-02-20

ApplicantBristol Medical Electronics Corp.

Decision Date1985-02-20

Product CodeDRX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

ME20 TRACERITE CLEAR VENT TAPE, ME30 TRACERITE NON is the device name listed in this FDA 510(k) record. The listed applicant is Bristol Medical Electronics Corp.. It received FDA 510(k) clearance on 1985-02-20 under 510(k) number K844856. The device is classified under product code DRX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ME20 TRACERITE CLEAR VENT TAPE, ME30 TRACERITE NON?

ME20 TRACERITE CLEAR VENT TAPE, ME30 TRACERITE NON is a medical device that received FDA 510(k) clearance on 1985-02-20. The listed applicant is Bristol Medical Electronics Corp.. The 510(k) number is K844856.

When did ME20 TRACERITE CLEAR VENT TAPE, ME30 TRACERITE NON receive FDA 510(k) clearance?

ME20 TRACERITE CLEAR VENT TAPE, ME30 TRACERITE NON received FDA 510(k) clearance on 1985-02-20, under 510(k) number K844856.

Who is the listed applicant for ME20 TRACERITE CLEAR VENT TAPE, ME30 TRACERITE NON?

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

What is the FDA product code for ME20 TRACERITE CLEAR VENT TAPE, ME30 TRACERITE NON?

The FDA product code for ME20 TRACERITE CLEAR VENT TAPE, ME30 TRACERITE NON is DRX.

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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.