The following data is part of a premarket notification filed by Elscint, Inc. with the FDA for Linear Scanner Probe Elscint Ltd. Tl-35.
| Device ID | K844189 |
| 510k Number | K844189 |
| Device Name: | LINEAR SCANNER PROBE ELSCINT LTD. TL-35 |
| Classification | Phantom, Anthropomorphic, Nuclear |
| Applicant | ELSCINT, INC. 775 NICHOLAS BLVD. Elk Grove Village, IL 60007 |
| Contact | Robert E Kenney |
| Correspondent | Robert E Kenney ELSCINT, INC. 775 NICHOLAS BLVD. Elk Grove Village, IL 60007 |
| Product Code | IYP |
| CFR Regulation Number | 892.1370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-10-30 |
| Decision Date | 1985-02-25 |