510(k) K973138
K973138 is an FDA 510(k) premarket notification submitted by Qrs Diagnostic, LLC for the device "SPIROCARD". The FDA issued a decision of Substantially Equivalent on October 28, 1998. 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
- October 28, 1998
- Date Received
- August 21, 1997
- 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