510(k) K960078
K960078 is an FDA 510(k) premarket notification submitted by Erich Jaeger, Inc. for the device "ASTHMA MONITOR". The FDA issued a decision of Substantially Equivalent on September 20, 1996. The device falls under product code BZG (Spirometer, Diagnostic), a Class II device regulated under 21 CFR 868.1840. Erich Jaeger, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 20, 1996
- Date Received
- January 5, 1996
- 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