510(k) K040549
K040549 is an FDA 510(k) premarket notification submitted by Cosmed Srl for the device "COSMED PONY FX". The FDA issued a decision of Substantially Equivalent on September 28, 2004. The device falls under product code BTY (Calculator, Predicted Values, Pulmonary Function), a Class II device regulated under 21 CFR 868.1890. Cosmed Srl has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 28, 2004
- Date Received
- March 2, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Calculator, Predicted Values, Pulmonary Function
- Device Class
- Class II
- Regulation Number
- 868.1890
- Review Panel
- AN
- Submission Type