FDA 510(k)

NEUTRALECT ADULT STANDARD, RETURN (REM) & PAEDIATRIC ELECTROSURGERY PLATE (MODIFICATION)

K-Number: K955261 · 1996-01-30

Decision Date1996-01-30

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

NEUTRALECT ADULT STANDARD, RETURN (REM) & PAEDIATRIC ELECTROSURGERY PLATE (MODIFICATION) is the device name listed in this FDA 510(k) record. The listed applicant is Msb , Ltd.. It received FDA 510(k) clearance on 1996-01-30 under 510(k) number K955261. 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 ELECTROSURGERY PLATE (MODIFICATION)?

NEUTRALECT ADULT STANDARD, RETURN (REM) & PAEDIATRIC ELECTROSURGERY PLATE (MODIFICATION) is a medical device that received FDA 510(k) clearance on 1996-01-30. The listed applicant is Msb , Ltd.. The 510(k) number is K955261.

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

NEUTRALECT ADULT STANDARD, RETURN (REM) & PAEDIATRIC ELECTROSURGERY PLATE (MODIFICATION) received FDA 510(k) clearance on 1996-01-30, under 510(k) number K955261.

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

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 ELECTROSURGERY PLATE (MODIFICATION)?

The FDA product code for NEUTRALECT ADULT STANDARD, RETURN (REM) & PAEDIATRIC ELECTROSURGERY PLATE (MODIFICATION) 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 K950587ECOTABS K944260ECG ELECTRODE K944817NEUTRALECT ADULT STANDARD, RETURN (REM), PAEDIATRIC STANDARD, RETURN (REM)

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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.