The following data is part of a premarket notification filed by Radiotherapeutics Corp. with the FDA for Sensor Sheath Ts1.
| Device ID | K962386 |
| 510k Number | K962386 |
| Device Name: | SENSOR SHEATH TS1 |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | RADIOTHERAPEUTICS CORP. 2680 BAYSHORE PKWY. SUITE 106 Mountain View, CA 94043 |
| Contact | Colin J Nichols |
| Correspondent | Colin J Nichols RADIOTHERAPEUTICS CORP. 2680 BAYSHORE PKWY. SUITE 106 Mountain View, CA 94043 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-20 |
| Decision Date | 1996-08-20 |