510(k) K000648
K000648 is an FDA 510(k) premarket notification submitted by Erich Jaeger GmbH for the device "SPIRO PRO". The FDA issued a decision of Substantially Equivalent on March 29, 2000. The device falls under product code BTY (Calculator, Predicted Values, Pulmonary Function), a Class II device regulated under 21 CFR 868.1890. Erich Jaeger GmbH has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 29, 2000
- Date Received
- February 28, 2000
- Clearance Type
- Special
- 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