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FDA 510(k)

MULE

K-Number: K934238 · 1994-10-26

ApplicantPenny and Giles Biometrics , Ltd.
Decision Date1994-10-26
Product CodeISD
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

MULE is the device name listed in this FDA 510(k) record. The listed applicant is Penny and Giles Biometrics , Ltd.. It received FDA 510(k) clearance on 1994-10-26 under 510(k) number K934238. The device is classified under product code ISD. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MULE?

MULE is a medical device that received FDA 510(k) clearance on 1994-10-26. The listed applicant is Penny and Giles Biometrics , Ltd.. The 510(k) number is K934238.

When did MULE receive FDA 510(k) clearance?

MULE received FDA 510(k) clearance on 1994-10-26, under 510(k) number K934238.

Who is the listed applicant for MULE?

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

What is the FDA product code for MULE?

The FDA product code for MULE is ISD.

Other records listing Penny and Giles Biometrics , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K962855ULE-2, MULE-2, HAND ACCESSORY KITK924416BOOST, MICE, GAMESYS.

Related Devices (Code: ISD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K202979MR Egometer Pedal, MR Ergometer Push/Pull, MR Ergometer Up/Down, MR Ergometer Dorsal Ankle Flex, MR Ergometer Pedal UltraLode B.V.K183296REAL Immersive SystemPenumbra, Inc.K112121ERGOSELECT/GEErgoline GmbHK080545ACTITRAINERActigraph, LLCK053078ERGOSELECT 100 K/P, ERGOSELECT 200 K/PErgoline GmbHK990866QUINTON MEDTRACK CR PLUS TREADMILLQuinton, Inc.

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.

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