The following data is part of a premarket notification filed by Philips Medical Systems(cleveland), Inc. with the FDA for Autospect.
Device ID | K090403 |
510k Number | K090403 |
Device Name: | AUTOSPECT |
Classification | System, Tomography, Computed, Emission |
Applicant | PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 595 MINER RD. Cleveland, OH 44143 |
Contact | Robert Z Phillips |
Correspondent | Robert Z Phillips PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 595 MINER RD. Cleveland, OH 44143 |
Product Code | KPS |
CFR Regulation Number | 892.1200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-02-17 |
Decision Date | 2009-03-31 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
AUTOSPECT 75499162 2253711 Live/Registered |
PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. 1998-06-08 |
AUTOSPECT 75216199 2176218 Dead/Cancelled |
Autospect Inc. 1996-12-20 |
AUTOSPECT 75212860 2176206 Dead/Cancelled |
Autospect Inc. 1996-12-13 |