510(k) K790334
K790334 is an FDA 510(k) premarket notification submitted by Draeger Medical, Inc. for the device "DRAGER ORM". The FDA issued a decision of Substantially Equivalent on March 7, 1979. The device falls under product code BYR (Transducer, Gas Pressure, Differential), a Class I device regulated under 21 CFR 868.2875. Draeger Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 7, 1979
- Date Received
- February 16, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Transducer, Gas Pressure, Differential
- Device Class
- Class I
- Regulation Number
- 868.2875
- Review Panel
- AN
- Submission Type