510(k) K080884
K080884 is an FDA 510(k) premarket notification submitted by Medtechs, LLC for the device "QHRV 1 - HEALTH ASSESSMENT SYSTEM". The FDA issued a decision of Substantially Equivalent on April 11, 2008. The device falls under product code DPS (Electrocardiograph), a Class II device regulated under 21 CFR 870.2340. Medtechs, LLC has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 11, 2008
- Date Received
- March 31, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Electrocardiograph
- Device Class
- Class II
- Regulation Number
- 870.2340
- Review Panel
- CV
- Submission Type