The following data is part of a premarket notification filed by Philips Medical Systems(cleveland), Inc. with the FDA for Infinion Software Features.
Device ID | K024066 |
510k Number | K024066 |
Device Name: | INFINION SOFTWARE FEATURES |
Classification | System, Nuclear Magnetic Resonance Imaging |
Applicant | PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 595 MINER RD. Cleveland, OH 44143 |
Contact | Duane Praschan |
Correspondent | Duane Praschan PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 595 MINER RD. Cleveland, OH 44143 |
Product Code | LNH |
CFR Regulation Number | 892.1000 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-12-09 |
Decision Date | 2003-02-04 |
Summary: | summary |