510(k) K001278
K001278 is an FDA 510(k) premarket notification submitted by Qrs Diagnostic, LLC for the device "SENSAIRE DIAGNOSTIC SPIROMETER". The FDA issued a decision of Substantially Equivalent on November 29, 2000. The device falls under product code BZG (Spirometer, Diagnostic), a Class II device regulated under 21 CFR 868.1840. Qrs Diagnostic, LLC has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 29, 2000
- Date Received
- April 21, 2000
- 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