The following data is part of a premarket notification filed by Cardiac Science Corporation with the FDA for Atria 3100, Atria 6100.
| Device ID | K060167 |
| 510k Number | K060167 |
| Device Name: | ATRIA 3100, ATRIA 6100 |
| Classification | Electrocardiograph |
| Applicant | CARDIAC SCIENCE CORPORATION 3303 MONTE VILLA PKWY. Bothell, WA 98021 |
| Contact | Cheryl Shea |
| Correspondent | Cheryl Shea CARDIAC SCIENCE CORPORATION 3303 MONTE VILLA PKWY. Bothell, WA 98021 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-01-23 |
| Decision Date | 2006-04-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812345022957 | K060167 | 000 |