510(k) K083735
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 18, 2009
- Date Received
- December 16, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
- Device Class
- Class II
- Regulation Number
- 870.2780
- Review Panel
- CV
- Submission Type