510(k) K201562
K201562 is an FDA 510(k) premarket notification submitted by Vitalograph Ireland, Ltd. for the device "Spirotrac". The FDA issued a decision of Substantially Equivalent on October 14, 2020. 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
- October 14, 2020
- Date Received
- June 10, 2020
- 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