510(k) K052650
K052650 is an FDA 510(k) premarket notification submitted by Merits Health Products Co., Ltd. for the device "PIONEER U601 SERIES ASPIRATOR". The FDA issued a decision of Substantially Equivalent on November 4, 2005. The device falls under product code BTA (Pump, Portable, Aspiration (Manual Or Powered)), a Class II device regulated under 21 CFR 878.4780. Merits Health Products Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 4, 2005
- Date Received
- September 26, 2005
- Clearance Type
- Abbreviated
- 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