The following data is part of a premarket notification filed by Perkins Mfg. Co. with the FDA for Tv Monitor (p12/17).
Device ID | K972136 |
510k Number | K972136 |
Device Name: | TV MONITOR (P12/17) |
Classification | System, X-ray, Angiographic |
Applicant | PERKINS MFG. CO. 1510 NORTH WASHINGTON AVE. Dallas, TX 75204 |
Contact | Jim Furse |
Correspondent | Jim Furse PERKINS MFG. CO. 1510 NORTH WASHINGTON AVE. Dallas, TX 75204 |
Product Code | IZI |
CFR Regulation Number | 892.1600 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-06-06 |
Decision Date | 1997-06-26 |