The following data is part of a premarket notification filed by Philips Medical Systems North America, Inc. with the FDA for Philips Easyvision Workstation.
Device ID | K990329 |
510k Number | K990329 |
Device Name: | PHILIPS EASYVISION WORKSTATION |
Classification | System, Nuclear Magnetic Resonance Imaging |
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 | LNH |
CFR Regulation Number | 892.1000 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-02-02 |
Decision Date | 1999-12-07 |
Summary: | summary |