510(k) K040313
K040313 is an FDA 510(k) premarket notification submitted by Del Mar Reynolds Medical, Ltd. for the device "HRV TOOLS". The FDA issued a decision of Substantially Equivalent on April 6, 2004. The device falls under product code DPS (Electrocardiograph), a Class II device regulated under 21 CFR 870.2340. Del Mar Reynolds Medical, Ltd. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 6, 2004
- Date Received
- February 9, 2004
- 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