510(k) K213984
K213984 is an FDA 510(k) premarket notification submitted by Shenzhen Zhengkang Technology Co., Ltd. for the device "Oximeter (Model: JZK-301,JZK-303,JZK-305,JZK-307)". The FDA issued a decision of Substantially Equivalent on Dec 16, 2022. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Shenzhen Zhengkang Technology Co., Ltd. has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 16, 2022
- Date Received
- Dec 20, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Oximeter
- Device Class
- Class II
- Regulation Number
- 870.2700
- Review Panel
- AN
- Submission Type
- 510(k)