510(k) K980876
K980876 is an FDA 510(k) premarket notification submitted by Erich Jaeger GmbH & Co. KG for the device "ASTHMA MONITOR AM2". The FDA issued a decision of Substantially Equivalent on August 14, 1998. The device falls under product code BZG (Spirometer, Diagnostic), a Class II device regulated under 21 CFR 868.1840. Erich Jaeger GmbH & Co. KG has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 14, 1998
- Date Received
- March 6, 1998
- 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