510(k) K093241
K093241 is an FDA 510(k) premarket notification submitted by Hersill, S.L. for the device "V7 PORTABLE SUCTION UNITS". The FDA issued a decision of Substantially Equivalent on April 27, 2010. The device falls under product code BTA (Pump, Portable, Aspiration (Manual Or Powered)), a Class II device regulated under 21 CFR 878.4780. Hersill, S.L. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 27, 2010
- Date Received
- October 15, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Pump, Portable, Aspiration (Manual Or Powered)
- Device Class
- Class II
- Regulation Number
- 878.4780
- Review Panel
- SU
- Submission Type