The following data is part of a premarket notification filed by Calypso Medical Technologies Inc with the FDA for Calypso 4d Localization System.
| Device ID | K080726 |
| 510k Number | K080726 |
| Device Name: | CALYPSO 4D LOCALIZATION SYSTEM |
| Classification | Accelerator, Linear, Medical |
| Applicant | CALYPSO MEDICAL TECHNOLOGIES INC 2101 FOURTH AVE SUITE 500 Seattle, WA 98121 |
| Contact | Eric Meier |
| Correspondent | Eric Meier CALYPSO MEDICAL TECHNOLOGIES INC 2101 FOURTH AVE SUITE 500 Seattle, WA 98121 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-14 |
| Decision Date | 2008-05-14 |
| Summary: | summary |