The following data is part of a premarket notification filed by Minrad, Inc. with the FDA for Drts Remote Control Drape.
| Device ID | K973067 |
| 510k Number | K973067 |
| Device Name: | DRTS REMOTE CONTROL DRAPE |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | MINRAD, INC. 6576 EAST QUAKER ST. Orchard Park, NY 14127 -2593 |
| Contact | John Mcneirney |
| Correspondent | John Mcneirney MINRAD, INC. 6576 EAST QUAKER ST. Orchard Park, NY 14127 -2593 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-18 |
| Decision Date | 1997-10-16 |