The following data is part of a premarket notification filed by Calypso Medical Technologies Inc with the FDA for Calypso Systems With Dynamic Edge Gating.
| Device ID | K112768 |
| 510k Number | K112768 |
| Device Name: | CALYPSO SYSTEMS WITH DYNAMIC EDGE GATING |
| Classification | System, Radiation Therapy, Charged-particle, Medical |
| Applicant | CALYPSO MEDICAL TECHNOLOGIES INC 2101 FOURTH AVE SUITE 500 Seattle, WA 98121 |
| Contact | Marcia Page |
| Correspondent | Marcia Page CALYPSO MEDICAL TECHNOLOGIES INC 2101 FOURTH AVE SUITE 500 Seattle, WA 98121 |
| Product Code | LHN |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-22 |
| Decision Date | 2011-11-18 |
| Summary: | summary |