510(k) K201265
K201265 is an FDA 510(k) premarket notification submitted by Nanjing Eco Microwave System Co., Ltd. for the device "Disposable Microwave Therapeutic Antennas". The FDA issued a decision of Substantially Equivalent on Jul 23, 2021. The device falls under product code NEY (System, Ablation, Microwave And Accessories), a Class II device regulated under 21 CFR 878.4400. Nanjing Eco Microwave System Co., Ltd. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 23, 2021
- Date Received
- May 11, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Ablation, Microwave And Accessories
- Device Class
- Class II
- Regulation Number
- 878.4400
- Review Panel
- SU
- Submission Type
- 510(k)