510(k) K190105
K190105 is an FDA 510(k) premarket notification submitted by Taiwan Biomaterial Co., Ltd. for the device "ZOOM Aspiration Pump". The FDA issued a decision of Substantially Equivalent on February 21, 2019. The device falls under product code JCX (Apparatus, Suction, Ward Use, Portable, Ac-Powered), a Class II device regulated under 21 CFR 878.4780. Taiwan Biomaterial Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 21, 2019
- Date Received
- January 22, 2019
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Apparatus, Suction, Ward Use, Portable, Ac-Powered
- Device Class
- Class II
- Regulation Number
- 878.4780
- Review Panel
- SU
- Submission Type