510(k) K212938
K212938 is an FDA 510(k) premarket notification submitted by Vitalograph Ireland, Ltd. for the device "Vitalograph Model 6000 Alpha". The FDA issued a decision of Substantially Equivalent on January 26, 2022. The device falls under product code BZG (Spirometer, Diagnostic), a Class II device regulated under 21 CFR 868.1840. Vitalograph Ireland, Ltd. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 26, 2022
- Date Received
- September 15, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Spirometer, Diagnostic
- Device Class
- Class II
- Regulation Number
- 868.1840
- Review Panel
- AN
- Submission Type