MULE

Exerciser, Measuring

PENNY AND GILES BIOMETRICS LTD.

The following data is part of a premarket notification filed by Penny And Giles Biometrics Ltd. with the FDA for Mule.

Pre-market Notification Details

• Device ID: K934238
• 510k Number: K934238
• Device Name: MULE
• Classification: Exerciser, Measuring
• Applicant: PENNY AND GILES BIOMETRICS LTD. BLACKWOOD GWENT NP22YD UNITED KINGDOM England, GB
• Contact: Ian Thomas
• Correspondent: Ian Thomas; PENNY AND GILES BIOMETRICS LTD. BLACKWOOD GWENT NP22YD UNITED KINGDOM England, GB
• Product Code: ISD
• CFR Regulation Number: 890.5360 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1993-08-30
• Decision Date: 1994-10-26