The following data is part of a premarket notification filed by Philips Medical Systems North America, Inc. with the FDA for Philips Easy Vision Family Workstation Option Cardirac Scoring.
Device ID | K002942 |
510k Number | K002942 |
Device Name: | PHILIPS EASY VISION FAMILY WORKSTATION OPTION CARDIRAC SCORING |
Classification | System, Image Processing, Radiological |
Applicant | PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. 710 BRIDGEPORT AVE. P.O. BOX 860 Shelton, CT 06484 -0197 |
Contact | Peter Altman |
Correspondent | Peter Altman PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. 710 BRIDGEPORT AVE. P.O. BOX 860 Shelton, CT 06484 -0197 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-09-21 |
Decision Date | 2000-12-19 |