510(k) K093211
K093211 is an FDA 510(k) premarket notification submitted by Cardiac Science Corporation for the device "CARECENTER MD". The FDA issued a decision of Substantially Equivalent on June 3, 2010. The device falls under product code DPS (Electrocardiograph), a Class II device regulated under 21 CFR 870.2340. Cardiac Science Corporation has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 3, 2010
- Date Received
- October 13, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrocardiograph
- Device Class
- Class II
- Regulation Number
- 870.2340
- Review Panel
- CV
- Submission Type