FDA 510(k)

BIOTRACE-N, NS, 410 AND RT

K-Number: K944496 · 1996-05-16

Decision Date1996-05-16

Product CodeDRX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

BIOTRACE-N, NS, 410 AND RT is the device name listed in this FDA 510(k) record. The listed applicant is Msb , Ltd.. It received FDA 510(k) clearance on 1996-05-16 under 510(k) number K944496. 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 BIOTRACE-N, NS, 410 AND RT?

BIOTRACE-N, NS, 410 AND RT is a medical device that received FDA 510(k) clearance on 1996-05-16. The listed applicant is Msb , Ltd.. The 510(k) number is K944496.

When did BIOTRACE-N, NS, 410 AND RT receive FDA 510(k) clearance?

BIOTRACE-N, NS, 410 AND RT received FDA 510(k) clearance on 1996-05-16, under 510(k) number K944496.

Who is the listed applicant for BIOTRACE-N, NS, 410 AND RT?

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

What is the FDA product code for BIOTRACE-N, NS, 410 AND RT?

The FDA product code for BIOTRACE-N, NS, 410 AND RT is DRX.

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Other records listing Msb , Ltd. as applicant

K980229MSB TENS ELECTRODES (DISPOSABLE)K944497UNILECT, MONITAB AND BIOTRACE-HR K955261NEUTRALECT ADULT STANDARD, RETURN (REM) & PAEDIATRIC ELECTROSURGERY PLATE (MODIFICATION)K950587ECOTABS K944260ECG ELECTRODE K944817NEUTRALECT ADULT STANDARD, RETURN (REM), PAEDIATRIC STANDARD, RETURN (REM)

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Related Devices (Code: DRX)

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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.