510(k) DEN210022
- Device
- PMD-200
- Applicant
- Medasense Biometrics , Ltd.
- 510(k) number
- DEN210022
- Product code
- QVE
- Decision
- Unknown (DENG)
- Decision date
- 2023-02-17
- Date received
- 2021-06-04
- Regulation
- 868.2200
- Classification name
- Adjunctive Pain Measurement Device For Anesthesiology
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Rachel Weissbrod
- Address
- 4 Hachilazon St. Ramat Gan IL 5252268 5252268
FDA Registration Numbers#
- 3015509718
- 3011782009
- 1930027
Source Documents#
510(k) summary PDF not indicated by FDA