510(k) K190568
K190568 is an FDA 510(k) premarket notification submitted by Morgan Scientific, Inc. for the device "ComPAS2 (Computerized Pulmonary Analysis System)". The FDA issued a decision of Substantially Equivalent on June 6, 2019. The device falls under product code BZG (Spirometer, Diagnostic), a Class II device regulated under 21 CFR 868.1840. Morgan Scientific, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 6, 2019
- Date Received
- March 6, 2019
- 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