The following data is part of a premarket notification filed by Midmark Corp. with the FDA for X-ray Collimating Devices.
| Device ID | K810598 |
| 510k Number | K810598 |
| Device Name: | X-RAY COLLIMATING DEVICES |
| Classification | Collimator, Automatic, Radiographic |
| Applicant | MIDMARK CORP. 60 Vista Dr Versailles, OH 45380 |
| Contact | Scott Gore |
| Correspondent | John T Davidson CARESTREAM HEALTH,INC. 150 VERONA STREET Rochester, NY 14608 |
| Product Code | IZW |
| CFR Regulation Number | 892.1610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-03-06 |
| Decision Date | 1981-04-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 60889976573785 | K810598 | 000 |
| 60889976573778 | K810598 | 000 |
| 60889976568811 | K810598 | 000 |
| 60889976567166 | K810598 | 000 |
| 60889976567159 | K810598 | 000 |
| 60889971058942 | K810598 | 000 |