Progreat Lambda
FDA 510(k) clearance K211078 · decided 2021-12-21
Clearance details
- K-number
- K211078
- Device name
- Progreat Lambda
- Applicant
- Terumo Clinical Supply Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2021-04-12
- Decision date
- 2021-12-21
- Days to decision
- 253 days
- Clearance type
- Traditional
- Product code
- DQO
- Device class
- 2
- Regulation number
- 870.1200
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Kakamigahara, JP
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.