The following data is part of a premarket notification filed by Perkins Mfg. Co. with the FDA for Video Annotator Model Pk2310.
| Device ID | K910384 |
| 510k Number | K910384 |
| Device Name: | VIDEO ANNOTATOR MODEL PK2310 |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| 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 | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-29 |
| Decision Date | 1991-04-16 |