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FDA 510(k)

ULE-2, MULE-2, HAND ACCESSORY KIT

K-Number: K962855 · 1996-12-11

ApplicantPenny and Giles Biometrics , Ltd.
Decision Date1996-12-11
Product CodeISD
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ULE-2, MULE-2, HAND ACCESSORY KIT 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 1996-12-11 under 510(k) number K962855. 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 ULE-2, MULE-2, HAND ACCESSORY KIT?

ULE-2, MULE-2, HAND ACCESSORY KIT is a medical device that received FDA 510(k) clearance on 1996-12-11. The listed applicant is Penny and Giles Biometrics , Ltd.. The 510(k) number is K962855.

When did ULE-2, MULE-2, HAND ACCESSORY KIT receive FDA 510(k) clearance?

ULE-2, MULE-2, HAND ACCESSORY KIT received FDA 510(k) clearance on 1996-12-11, under 510(k) number K962855.

Who is the listed applicant for ULE-2, MULE-2, HAND ACCESSORY KIT?

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 ULE-2, MULE-2, HAND ACCESSORY KIT?

The FDA product code for ULE-2, MULE-2, HAND ACCESSORY KIT is ISD.

Related Clinical Trials

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.

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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.

K934238MULEK924416BOOST, 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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