510(k) K870442
K870442 is an FDA 510(k) premarket notification submitted by Vital Science Corp. for the device "QUANTASCOPE". The FDA issued a decision of SN on August 11, 1987. The device falls under product code DXR (Ballistocardiograph), a Class II device regulated under 21 CFR 870.2320.
Clearance Details
- Decision
- SN ()
- Decision Date
- August 11, 1987
- Date Received
- February 3, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ballistocardiograph
- Device Class
- Class II
- Regulation Number
- 870.2320
- Review Panel
- CV
- Submission Type