The following data is part of a premarket notification filed by Teratech Corp. with the FDA for Teratech Model 8ioc4, 8iol4 & 10lap4 Probes.
| Device ID | K043278 |
| 510k Number | K043278 |
| Device Name: | TERATECH MODEL 8IOC4, 8IOL4 & 10LAP4 PROBES |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | TERATECH CORP. PO BOX 10074 13221 NE TEEM LOOP ROAD Bainbridge Island, WA 98110 |
| Contact | Charles F Hottinger |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | ITX |
| Subsequent Product Code | IYN |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-11-26 |
| Decision Date | 2004-12-13 |
| Summary: | summary |