The following data is part of a premarket notification filed by Philips Medical Systems, Inc. with the FDA for Diagnost 76 Family*r/f Systems - Release 4.4.
Device ID | K924593 |
510k Number | K924593 |
Device Name: | DIAGNOST 76 FAMILY*R/F SYSTEMS - RELEASE 4.4 |
Classification | Device, Spot-film |
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 | IXL |
CFR Regulation Number | 892.1670 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-09-10 |
Decision Date | 1992-11-24 |