PULSERA

System, X-ray, Mobile

PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.

The following data is part of a premarket notification filed by Philips Medical Systems North America Co. with the FDA for Pulsera.

Pre-market Notification Details

• Device ID: K061685
• 510k Number: K061685
• Device Name: PULSERA
• Classification: System, X-ray, Mobile
• Applicant: PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. 22100 BOTHELL EVERETT HWY. P.O. BOX 3003, MS 915 Bothell, WA 98041 -3003
• Contact: Joseph S Arnaudo
• Correspondent: Marc M Mouser; UNDERWRITERS LABORATORIES, INC. 2600 NW LAKE RD. Camas, WA 98607 -9526
• Product Code: IZL
• CFR Regulation Number: 892.1720 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2006-06-15
• Decision Date: 2006-09-15
• Summary: summary