SWIP

System, Nuclear Magnetic Resonance Imaging

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

The following data is part of a premarket notification filed by Philips Medical Systems Nederland B.v. with the FDA for Swip.

Pre-market Notification Details

• Device ID: K131241
• 510k Number: K131241
• Device Name: SWIP
• Classification: System, Nuclear Magnetic Resonance Imaging
• Applicant: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. 595 MINER RD Cleveland, OH 44143
• Contact: Susan Quick
• Correspondent: Susan Quick; PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. 595 MINER RD Cleveland, OH 44143
• Product Code: LNH
• CFR Regulation Number: 892.1000 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-05-01
• Decision Date: 2013-08-30
• Summary: summary