PMD-200
FDA 510(k) clearance DEN210022 · decided 2023-02-17
Clearance details
- K-number
- DEN210022
- Device name
- PMD-200
- Applicant
- Medasense Biometrics , Ltd.
- Decision
- Unknown
- Date received
- 2021-06-04
- Decision date
- 2023-02-17
- Days to decision
- 623 days
- Clearance type
- Direct
- Product code
- QVE
- Device class
- 2
- Regulation number
- 868.2200
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Ramat Gan, IL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.