510(k) K851102
K851102 is an FDA 510(k) premarket notification submitted by Sonicaid, Inc. for the device "VASOSCREEN IMPEDANCE PLETHYSMOGRAPH". The FDA issued a decision of Substantially Equivalent on May 16, 1985. The device falls under product code DQB (Phlebograph, Impedance), a Class II device regulated under 21 CFR 870.2750. Sonicaid, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 16, 1985
- Date Received
- March 19, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Phlebograph, Impedance
- Device Class
- Class II
- Regulation Number
- 870.2750
- Review Panel
- CV
- Submission Type