The following data is part of a premarket notification filed by Philips Medical Systems North America, Inc. with the FDA for Allura Xper Fd20.
Device ID | K033737 |
510k Number | K033737 |
Device Name: | ALLURA XPER FD20 |
Classification | Interventional Fluoroscopic X-ray System |
Applicant | PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. VEENPLUIS 4-6 P.O. BOX 10000 5680 Da Best, NL 5680 |
Contact | Lynn Harmer |
Correspondent | Lynn Harmer UNDERWRITERS LABORATORIES, INC. 2600 NW LAKE RD. Camas, WA 98607 -9526 |
Product Code | OWB |
Subsequent Product Code | IZI |
Subsequent Product Code | JAA |
CFR Regulation Number | 892.1650 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2003-11-28 |
Decision Date | 2003-12-09 |
Summary: | summary |