The following data is part of a premarket notification filed by Tee-kay Applied Technology with the FDA for Texas Interface Pressure Evaluator-tipe.
| Device ID | K831800 |
| 510k Number | K831800 |
| Device Name: | TEXAS INTERFACE PRESSURE EVALUATOR-TIPE |
| Classification | System, Pressure Measurement, Intermittent |
| Applicant | TEE-KAY APPLIED TECHNOLOGY 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JFC |
| CFR Regulation Number | 890.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-05-23 |
| Decision Date | 1983-08-16 |