510(k) K220351
K220351 is an FDA 510(k) premarket notification submitted by Chronisense Medical, Ltd. for the device "Polso Watch". The FDA issued a decision of Substantially Equivalent on Nov 18, 2022. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 18, 2022
- Date Received
- Feb 7, 2022
- 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)