510(k) K202837
K202837 is an FDA 510(k) premarket notification submitted by Monitored Therapeutics, Inc. for the device "GoSpiro". The FDA issued a decision of Substantially Equivalent on December 4, 2020. The device falls under product code BZG (Spirometer, Diagnostic), a Class II device regulated under 21 CFR 868.1840. Monitored Therapeutics, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 4, 2020
- Date Received
- September 25, 2020
- Clearance Type
- Special
- 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