Gili Pro BioSensor (also known as “Gili BioSensor System”)
FDA 510(k) clearance DEN200038 · decided 2021-04-01
Clearance details
- K-number
- DEN200038
- Device name
- Gili Pro BioSensor (also known as “Gili BioSensor System”)
- Applicant
- Continuse Biometrics , Ltd.
- Decision
- Unknown
- Date received
- 2020-06-12
- Decision date
- 2021-04-01
- Days to decision
- 293 days
- Clearance type
- Direct
- Product code
- QOK
- Device class
- 2
- Regulation number
- 870.2786
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Tel-Aviv, IL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.