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 |