510(k) K100319
MERIT MANIFOLD WITH INTEGRATED TRANSDUCER, MODEL 203LTCHN-R; 503LTCHN-R; 203LTPHN-R,203LTCHWN-R; 503LTCHWN-R; 203L by
Merit Medical Systems, Inc.
— Product Code DTL
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 28, 2010
- Date Received
- February 4, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
- Device Class
- Class II
- Regulation Number
- 870.4290
- Review Panel
- CV
- Submission Type