MULE— 510(k) K934238

Name: FDA 510(k) clearance K934238
Creator: U.S. Food and Drug Administration
Published: 1994-10-26

Substantially Equivalent

Penny and Giles Biometrics , Ltd.

FDA 510(k) clearance K934238 for MULE, Substantially Equivalent on 1994-10-26. Applicant: Penny and Giles Biometrics , Ltd.. Device class: 2.

Clearance details

Applicant: Penny and Giles Biometrics , Ltd.
Product code: Code ISD
Device class: Class 2
Regulation: 21 CFR 890.5360
Advisory panel: Physical Medicine
Date received: 1993-08-30
Decision date: 1994-10-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: England, GB

Download summary PDF View on FDA.gov ↗

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More clearances from Penny and Giles Biometrics , Ltd.

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K962855 — ULE-2, MULE-2, HAND ACCESSORY KIT1996-12-11
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Adverse events under product code ISD

product code ISD

Other: 2
Total: 2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.