510(k) K954140
K954140 is an FDA 510(k) premarket notification submitted by Erich Jaeger GmbH & Co. KG for the device "MASTERSCREEN IOS". The FDA issued a decision of Substantially Equivalent on December 14, 1995. 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
- December 14, 1995
- Date Received
- September 1, 1995
- 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