The following data is part of a premarket notification filed by Cardiac Science Corporation with the FDA for Carecenter Md.
| Device ID | K093211 |
| 510k Number | K093211 |
| Device Name: | CARECENTER MD |
| Classification | Electrocardiograph |
| Applicant | CARDIAC SCIENCE CORPORATION 3303 MONTE VILLA PKWY. Bothell, WA 98021 |
| Contact | Theresa Myers |
| Correspondent | Theresa Myers CARDIAC SCIENCE CORPORATION 3303 MONTE VILLA PKWY. Bothell, WA 98021 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-13 |
| Decision Date | 2010-06-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812345029949 | K093211 | 000 |
| 00812345023510 | K093211 | 000 |
| 00817655020174 | K093211 | 000 |
| 00817655020167 | K093211 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() CARECENTER MD 77725880 4127266 Dead/Cancelled |
Cardiac Science Corporation 2009-04-30 |
![]() CARECENTER MD 77725873 4127265 Dead/Cancelled |
Cardiac Science Corporation 2009-04-30 |