The following data is part of a premarket notification filed by Technicare Corp. with the FDA for Technicare 720 Hps Ct Scanner.
| Device ID | K854340 |
| 510k Number | K854340 |
| Device Name: | TECHNICARE 720 HPS CT SCANNER |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | TECHNICARE CORP. P.O. BOX 5130 Cleveland, OH 44101 |
| Contact | Raymond E Ursick |
| Correspondent | Raymond E Ursick TECHNICARE CORP. P.O. BOX 5130 Cleveland, OH 44101 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-28 |
| Decision Date | 1985-11-15 |