510(k) K180115
K180115 is an FDA 510(k) premarket notification submitted by Taiwan Biomaterial Co., Ltd. for the device "TWBM Pump". The FDA issued a decision of Substantially Equivalent on Jul 24, 2018. 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 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 24, 2018
- Date Received
- Jan 16, 2018
- Clearance Type
- Traditional
- 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
- 510(k)