510(k) K853360
K853360 is an FDA 510(k) premarket notification submitted by Erich Jaeger, Inc. for the device "N20 TEST". The FDA issued a decision of Substantially Equivalent on September 3, 1985. The device falls under product code CBR (Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)), a Class II device regulated under 21 CFR 868.1700. Erich Jaeger, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 3, 1985
- Date Received
- August 12, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)
- Device Class
- Class II
- Regulation Number
- 868.1700
- Review Panel
- AN
- Submission Type