The following data is part of a premarket notification filed by Circadian, Inc. with the FDA for Scanmate Iii.
| Device ID | K921878 |
| 510k Number | K921878 |
| Device Name: | SCANMATE III |
| Classification | Phantom, Anthropomorphic, Nuclear |
| Applicant | CIRCADIAN, INC. 16303 PANORAMIC WAY San Leandro, CA 94578 |
| Contact | Gary J Allsebrook |
| Correspondent | Gary J Allsebrook CIRCADIAN, INC. 16303 PANORAMIC WAY San Leandro, CA 94578 |
| Product Code | IYP |
| CFR Regulation Number | 892.1370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-20 |
| Decision Date | 1992-09-11 |