510(k) K002197
K002197 is an FDA 510(k) premarket notification submitted by Cardionics, Inc. for the device "CARTOUCH". The FDA issued a decision of Substantially Equivalent on Dec 27, 2000. The device falls under product code DPS (Electrocardiograph), a Class II device regulated under 21 CFR 870.2340. Cardionics, Inc. has 1 other 510(k) clearance on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 27, 2000
- Date Received
- Jul 20, 2000
- Clearance Type
- Abbreviated
- 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
- 510(k)