510(k) K945929
K945929 is an FDA 510(k) premarket notification submitted by Sscor for the device "S-SCORT(R)DUET MODEL 2014 PORTABLE SUCTION PUMP". The FDA issued a decision of Substantially Equivalent on December 22, 1994. The device falls under product code BTA (Pump, Portable, Aspiration (Manual Or Powered)), a Class II device regulated under 21 CFR 878.4780. Sscor has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 22, 1994
- Date Received
- December 5, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pump, Portable, Aspiration (Manual Or Powered)
- Device Class
- Class II
- Regulation Number
- 878.4780
- Review Panel
- SU
- Submission Type