The following data is part of a premarket notification filed by Teratech Corp. with the FDA for Teratech, Model 2000 Imaging Imaging.
| Device ID | K992505 |
| 510k Number | K992505 |
| Device Name: | TERATECH, MODEL 2000 IMAGING IMAGING |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | TERATECH CORP. 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Sheila Hemeon-heyer |
| Correspondent | Sheila Hemeon-heyer TERATECH CORP. 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-27 |
| Decision Date | 1999-11-10 |
| Summary: | summary |