PALMSCAN AP2000; PALMSCAN A2000; PALMSCAN P2000

System, Imaging, Pulsed Echo, Ultrasonic

MICRO MEDICAL DEVICES, INC.

The following data is part of a premarket notification filed by Micro Medical Devices, Inc. with the FDA for Palmscan Ap2000; Palmscan A2000; Palmscan P2000.

Pre-market Notification Details

• Device ID: K043287
• 510k Number: K043287
• Device Name: PALMSCAN AP2000; PALMSCAN A2000; PALMSCAN P2000
• Classification: System, Imaging, Pulsed Echo, Ultrasonic
• Applicant: MICRO MEDICAL DEVICES, INC. 5308 DERRY AVE., SUITE I-204 Agoura Hills, CA 91301
• Contact: Rafi Israel
• Correspondent: Alfredo J Quattrone; CALIFORNIA DEPARTMENT OF HEALTH SERVICES 1500 CAPITOL AVENUE MAILSTOP 7602 Sacramento, CA 95814
• Product Code: IYO
• CFR Regulation Number: 892.1560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2004-11-29
• Decision Date: 2004-12-10
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00853569007030	K043287	000
00853569007023	K043287	000
00853569007016	K043287	000
00853569007009	K043287	000