The following data is part of a premarket notification filed by Philips Medical Systems Nederland B.v. with the FDA for Xperguide.
Device ID | K131263 |
510k Number | K131263 |
Device Name: | XPERGUIDE |
Classification | Interventional Fluoroscopic X-ray System |
Applicant | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. VEENPLUIS 4-6 Best, NL 5684 Pc |
Contact | Jos V Vroonhoven |
Correspondent | Jos V Vroonhoven PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. VEENPLUIS 4-6 Best, NL 5684 Pc |
Product Code | OWB |
CFR Regulation Number | 892.1650 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-05-03 |
Decision Date | 2013-07-24 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00884838059252 | K131263 | 000 |