510(k) K201887
K201887 is an FDA 510(k) premarket notification submitted by Surepulse Medical Limited for the device "VS Newborn Heart Rate Monitor". The FDA issued a decision of Substantially Equivalent on Jul 23, 2021. 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
- Jul 23, 2021
- Date Received
- Jul 8, 2020
- 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)