510(k) K042943
K042943 is an FDA 510(k) premarket notification submitted by NOUVAG AG for the device "NOUVAG AG - VACUSON 40 AND VACUSON 60". The FDA issued a decision of Substantially Equivalent on December 17, 2004. The device falls under product code BTA (Pump, Portable, Aspiration (Manual Or Powered)), a Class II device regulated under 21 CFR 878.4780. NOUVAG AG has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 17, 2004
- Date Received
- October 25, 2004
- 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