510(k) K112959
K112959 is an FDA 510(k) premarket notification submitted by Philips Health Care for the device "CALG-STR EXERCISE ECG ANALYSIS ALGORITHM". The FDA issued a decision of Substantially Equivalent on Jan 26, 2012. The device falls under product code DPS (Electrocardiograph), a Class II device regulated under 21 CFR 870.2340. Philips Health Care has 19 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 26, 2012
- Date Received
- Oct 4, 2011
- 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
- 510(k)