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 |