510(k) K221030
K221030 is an FDA 510(k) premarket notification submitted by Vitalograph Ireland, Ltd. for the device "Model 9100 PFT/DICO". The FDA issued a decision of Substantially Equivalent on July 15, 2022. The device falls under product code BTY (Calculator, Predicted Values, Pulmonary Function), a Class II device regulated under 21 CFR 868.1890. Vitalograph Ireland, Ltd. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 15, 2022
- Date Received
- April 7, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Calculator, Predicted Values, Pulmonary Function
- Device Class
- Class II
- Regulation Number
- 868.1890
- Review Panel
- AN
- Submission Type