The following data is part of a premarket notification filed by Teratech Corp. with the FDA for Teratech Model 8ec4 Endocavity Smart Probe.
| Device ID | K010883 |
| 510k Number | K010883 |
| Device Name: | TERATECH MODEL 8EC4 ENDOCAVITY SMART PROBE |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | TERATECH CORP. 19030 PORTOS DR. Saratoga, CA 95070 |
| Contact | Charles F Hottinger |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2001-03-23 |
| Decision Date | 2001-04-06 |