FDA 510(k)

NEUTRALECT ADULT STANDARD, RETURN (REM), PAEDIATRIC STANDARD, RETURN (REM)

K-Number: K944817 · 1994-11-09

Decision Date1994-11-09

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

NEUTRALECT ADULT STANDARD, RETURN (REM), PAEDIATRIC STANDARD, RETURN (REM) is the device name listed in this FDA 510(k) record. The listed applicant is Msb , Ltd.. It received FDA 510(k) clearance on 1994-11-09 under 510(k) number K944817. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEUTRALECT ADULT STANDARD, RETURN (REM), PAEDIATRIC STANDARD, RETURN (REM)?

NEUTRALECT ADULT STANDARD, RETURN (REM), PAEDIATRIC STANDARD, RETURN (REM) is a medical device that received FDA 510(k) clearance on 1994-11-09. The listed applicant is Msb , Ltd.. The 510(k) number is K944817.

When did NEUTRALECT ADULT STANDARD, RETURN (REM), PAEDIATRIC STANDARD, RETURN (REM) receive FDA 510(k) clearance?

NEUTRALECT ADULT STANDARD, RETURN (REM), PAEDIATRIC STANDARD, RETURN (REM) received FDA 510(k) clearance on 1994-11-09, under 510(k) number K944817.

Who is the listed applicant for NEUTRALECT ADULT STANDARD, RETURN (REM), PAEDIATRIC STANDARD, RETURN (REM)?

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 NEUTRALECT ADULT STANDARD, RETURN (REM), PAEDIATRIC STANDARD, RETURN (REM)?

The FDA product code for NEUTRALECT ADULT STANDARD, RETURN (REM), PAEDIATRIC STANDARD, RETURN (REM) is GEI.

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Other records listing Msb , Ltd. as applicant

K980229MSB TENS ELECTRODES (DISPOSABLE)K944497UNILECT, MONITAB AND BIOTRACE-HR K944496BIOTRACE-N, NS, 410 AND RT K955261NEUTRALECT ADULT STANDARD, RETURN (REM) & PAEDIATRIC ELECTROSURGERY PLATE (MODIFICATION)K950587ECOTABS K944260ECG ELECTRODE

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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.