510(k) K213754
K213754 is an FDA 510(k) premarket notification submitted by Inofab Saglik Teknolojileri A.S for the device "SpiroHome Personal, SpiroHome Clinic". The FDA issued a decision of Substantially Equivalent on June 12, 2023. The device falls under product code BZG (Spirometer, Diagnostic), a Class II device regulated under 21 CFR 868.1840.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 12, 2023
- Date Received
- November 30, 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