The following data is part of a premarket notification filed by Philips Medical Systems, Inc. with the FDA for Philips Uro Diagnost Mrf.
Device ID | K911098 |
510k Number | K911098 |
Device Name: | PHILIPS URO DIAGNOST MRF |
Classification | Table, Radiographic, Tilting |
Applicant | PHILIPS MEDICAL SYSTEMS, INC. VEENPLUIS 4-6 P.O. BOX 10000 5680 Da Best, NL |
Contact | William G Mcmahon |
Correspondent | William G Mcmahon PHILIPS MEDICAL SYSTEMS, INC. VEENPLUIS 4-6 P.O. BOX 10000 5680 Da Best, NL |
Product Code | IXR |
CFR Regulation Number | 892.1980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-03-12 |
Decision Date | 1991-07-03 |