The following data is part of a premarket notification filed by Perkins Mfg. Co. with the FDA for Cine Camera Control Model Pk2037.
Device ID | K896615 |
510k Number | K896615 |
Device Name: | CINE CAMERA CONTROL MODEL PK2037 |
Classification | Camera, X-ray, Fluorographic, Cine Or Spot |
Applicant | PERKINS MFG. CO. 1510 NORTH WASHINGTON AVE. Dallas, TX 75204 |
Contact | James C Furse |
Correspondent | James C Furse PERKINS MFG. CO. 1510 NORTH WASHINGTON AVE. Dallas, TX 75204 |
Product Code | IZJ |
CFR Regulation Number | 892.1620 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-11-21 |
Decision Date | 1990-01-04 |