510(k) K152091
K152091 is an FDA 510(k) premarket notification submitted by Jiangsu Konsung Bio-Medical Science & Technology Co., Ltd. for the device "Fingertip Pulse Oximeter". The FDA issued a decision of Substantially Equivalent on August 18, 2016. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Jiangsu Konsung Bio-Medical Science & Technology Co., Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 18, 2016
- Date Received
- July 27, 2015
- 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