The following data is part of a premarket notification filed by Cardiac Insight, Inc. with the FDA for Stealth Monitor, Stealth Docking Cable, Stealth Display And Storage Device.
| Device ID | K130288 |
| 510k Number | K130288 |
| Device Name: | STEALTH MONITOR, STEALTH DOCKING CABLE, STEALTH DISPLAY AND STORAGE DEVICE |
| Classification | Recorder, Magnetic Tape, Medical |
| Applicant | CARDIAC INSIGHT, INC. 5672 FLAGLER ROAD Nordland, WA 98358 |
| Contact | Deborah Sheffield |
| Correspondent | Deborah Sheffield CARDIAC INSIGHT, INC. 5672 FLAGLER ROAD Nordland, WA 98358 |
| Product Code | DSH |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-05 |
| Decision Date | 2013-05-29 |