The following data is part of a premarket notification filed by Calypso Medical Technologies Inc with the FDA for Surface Beacon Transponders.
| Device ID | K112841 |
| 510k Number | K112841 |
| Device Name: | SURFACE BEACON TRANSPONDERS |
| Classification | Accelerator, Linear, 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 | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-29 |
| Decision Date | 2012-02-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850011006016 | K112841 | 000 |