510(k) K042595
K042595 is an FDA 510(k) premarket notification submitted by Morgan Scientific, Inc. for the device "SPIRO'AIR". The FDA issued a decision of Substantially Equivalent on May 4, 2005. 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
- May 4, 2005
- Date Received
- September 23, 2004
- 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