The following data is part of a premarket notification filed by Perkins Mfg. Co. with the FDA for 1 Video Tape Recorder Model Bk-224 H.
Device ID | K892934 |
510k Number | K892934 |
Device Name: | 1 VIDEO TAPE RECORDER MODEL BK-224 H |
Classification | Image-intensified Fluoroscopic X-ray System, Mobile |
Applicant | PERKINS MFG. CO. 1510 NORTH WASHINGTON AVE. Dallas, TX 75204 |
Contact | Dennis Carroll |
Correspondent | Dennis Carroll PERKINS MFG. CO. 1510 NORTH WASHINGTON AVE. Dallas, TX 75204 |
Product Code | OXO |
CFR Regulation Number | 892.1650 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-04-21 |
Decision Date | 1989-07-20 |