The following data is part of a premarket notification filed by Technicare Corp. with the FDA for Nuclear 700 Medicine Mechanical Posit-.
| Device ID | K843716 |
| 510k Number | K843716 |
| Device Name: | NUCLEAR 700 MEDICINE MECHANICAL POSIT- |
| Classification | Camera, Scintillation (gamma) |
| 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 | IYX |
| CFR Regulation Number | 892.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-24 |
| Decision Date | 1984-12-17 |