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 |