510(k) K111601
K111601 is an FDA 510(k) premarket notification submitted by Medical Predictive Science Corp. for the device "HERO". The FDA issued a decision of Substantially Equivalent on Jul 8, 2011. The device falls under product code DPS (Electrocardiograph), a Class II device regulated under 21 CFR 870.2340. Medical Predictive Science Corp. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 8, 2011
- Date Received
- Jun 8, 2011
- Clearance Type
- Special
- 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)