The following data is part of a premarket notification filed by Mallinckrodt Group, Inc. with the FDA for Hydraview 1000 Digital Image Process/stor Device.
| Device ID | K913264 |
| 510k Number | K913264 |
| Device Name: | HYDRAVIEW 1000 DIGITAL IMAGE PROCESS/STOR DEVICE |
| Classification | System, Image Processing, Radiological |
| Applicant | MALLINCKRODT GROUP, INC. 2111 EAST GALBRAITH RD. P.O. BOX 156305 Cincinnati, OH 45215 -6305 |
| Contact | Mark L Friedman |
| Correspondent | Mark L Friedman MALLINCKRODT GROUP, INC. 2111 EAST GALBRAITH RD. P.O. BOX 156305 Cincinnati, OH 45215 -6305 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-23 |
| Decision Date | 1991-11-01 |