The following data is part of a premarket notification filed by Terarecon, Inc. with the FDA for Rtr-2000/rtr-4000.
Device ID | K974307 |
510k Number | K974307 |
Device Name: | RTR-2000/RTR-4000 |
Classification | System, X-ray, Tomography, Computed |
Applicant | TERARECON, INC. 280 UTAH AVE., SUITE 100 South San Francisco, CA 94080 |
Contact | Tim Frandsen |
Correspondent | Tim Frandsen TERARECON, INC. 280 UTAH AVE., SUITE 100 South San Francisco, CA 94080 |
Product Code | JAK |
CFR Regulation Number | 892.1750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-11-17 |
Decision Date | 1998-02-13 |
Summary: | summary |