The following data is part of a premarket notification filed by Comet Ltd. C/o Radiology Resources, Inc. with the FDA for Di2000/hs-45-150 X-ray Tube Insert.
| Device ID | K910842 |
| 510k Number | K910842 |
| Device Name: | DI2000/HS-45-150 X-RAY TUBE INSERT |
| Classification | Assembly, Tube Housing, X-ray, Diagnostic |
| Applicant | COMET LTD. C/O RADIOLOGY RESOURCES, INC. WALDEGGSTRASSE 72 CH-3097 LIEBEFELD-BERNE Switzerland, CH |
| Contact | Suffredini |
| Correspondent | Suffredini COMET LTD. C/O RADIOLOGY RESOURCES, INC. WALDEGGSTRASSE 72 CH-3097 LIEBEFELD-BERNE Switzerland, CH |
| Product Code | ITY |
| CFR Regulation Number | 892.1760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-27 |
| Decision Date | 1991-03-06 |