510(k) K853390
K853390 is an FDA 510(k) premarket notification submitted by Erich Jaeger, Inc. for the device "INFANT BODY TEST". The FDA issued a decision of Substantially Equivalent on February 5, 1986. The device falls under product code CCM (Plethysmograph, Pressure), a Class II device regulated under 21 CFR 868.1750. Erich Jaeger, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 5, 1986
- Date Received
- August 13, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plethysmograph, Pressure
- Device Class
- Class II
- Regulation Number
- 868.1750
- Review Panel
- AN
- Submission Type