The following data is part of a premarket notification filed by Proportional Technologies, Inc. with the FDA for Protec (1024).
| Device ID | K963730 |
| 510k Number | K963730 |
| Device Name: | PROTEC (1024) |
| Classification | System, Tomography, Computed, Emission |
| Applicant | PROPORTIONAL TECHNOLOGIES, INC. 8018 EL RIO Houston, TX 77054 |
| Contact | Jeffrey L Lacy, Ph.d. |
| Correspondent | Jeffrey L Lacy, Ph.d. PROPORTIONAL TECHNOLOGIES, INC. 8018 EL RIO Houston, TX 77054 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-16 |
| Decision Date | 1997-02-10 |
| Summary: | summary |