Vitalograph Model 6000 Alpha
FDA 510(k) clearance K212938 · decided 2022-01-26
Clearance details
- K-number
- K212938
- Device name
- Vitalograph Model 6000 Alpha
- Applicant
- Vitalograph Ireland, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2021-09-15
- Decision date
- 2022-01-26
- Days to decision
- 133 days
- Clearance type
- Traditional
- Product code
- BZG
- Device class
- 2
- Regulation number
- 868.1840
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Ennis Co Clare, IE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.