The following data is part of a premarket notification filed by Cardiac Science Corporation with the FDA for Mysense Heart.
| Device ID | K113176 |
| 510k Number | K113176 |
| Device Name: | MYSENSE HEART |
| Classification | Recorder, Magnetic Tape, Medical |
| Applicant | CARDIAC SCIENCE CORPORATION 3303 MONTE VILLA PKWY. Bothell, WA 98021 |
| Contact | Neil Sheller |
| Correspondent | Neil Sheller CARDIAC SCIENCE CORPORATION 3303 MONTE VILLA PKWY. Bothell, WA 98021 |
| Product Code | DSH |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-28 |
| Decision Date | 2011-12-21 |
| Summary: | summary |