The following data is part of a premarket notification filed by Medi-physics Inc. Dba Nycomed Amersham Imaging with the FDA for Krypton Masks & Tubing.
| Device ID | K811118 |
| 510k Number | K811118 |
| Device Name: | KRYPTON MASKS & TUBING |
| Classification | System, Rebreathing, Radionuclide |
| Applicant | MEDI-PHYSICS INC. DBA NYCOMED AMERSHAM IMAGING 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IYT |
| CFR Regulation Number | 892.1390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-04-24 |
| Decision Date | 1981-06-02 |