The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for E.cam Computer.
| Device ID | K992731 |
| 510k Number | K992731 |
| Device Name: | E.CAM COMPUTER |
| Classification | System, Tomography, Computed, Emission |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 2501 NORTH BARRINGTON RD. Hoffman Estates, IL 60195 -7372 |
| Contact | Robert W Callahan |
| Correspondent | Robert W Callahan SIEMENS MEDICAL SOLUTIONS USA, INC. 2501 NORTH BARRINGTON RD. Hoffman Estates, IL 60195 -7372 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-13 |
| Decision Date | 1999-11-10 |
| Summary: | summary |