The following data is part of a premarket notification filed by Par Microsystems Corp. with the FDA for Imagenet Digital Ophthalmic Imaging System.
| Device ID | K870039 |
| 510k Number | K870039 |
| Device Name: | IMAGENET DIGITAL OPHTHALMIC IMAGING SYSTEM |
| Classification | Recorder, Paper Chart |
| Applicant | PAR MICROSYSTEMS CORP. 220 SENECA TURNPIKE New Hartford, NY 13413 |
| Contact | James L Cambier,phd |
| Correspondent | James L Cambier,phd PAR MICROSYSTEMS CORP. 220 SENECA TURNPIKE New Hartford, NY 13413 |
| Product Code | DSF |
| CFR Regulation Number | 870.2810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-01-05 |
| Decision Date | 1987-02-12 |