The following data is part of a premarket notification filed by Cardiac Science Corporation with the FDA for Q-stress And Heartstride, Models Qstress/q40 And H4/h4s.
| Device ID | K082173 |
| 510k Number | K082173 |
| Device Name: | Q-STRESS AND HEARTSTRIDE, MODELS QSTRESS/Q40 AND H4/H4S |
| Classification | Electrocardiograph |
| Applicant | CARDIAC SCIENCE CORPORATION 3303 MONTE VILLA PKWY. Bothell, WA 98021 |
| Contact | Beverly Magrane |
| Correspondent | Beverly Magrane CARDIAC SCIENCE CORPORATION 3303 MONTE VILLA PKWY. Bothell, WA 98021 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-01 |
| Decision Date | 2008-08-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812345022827 | K082173 | 000 |