510(k) K051192
K051192 is an FDA 510(k) premarket notification submitted by Praxair, Inc. for the device "PRAXAIR MEDICAL AIR MIXER". The FDA issued a decision of Substantially Equivalent on September 6, 2005. The device falls under product code BZR (Mixer, Breathing Gases, Anesthesia Inhalation), a Class II device regulated under 21 CFR 868.5330. Praxair, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 6, 2005
- Date Received
- May 10, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mixer, Breathing Gases, Anesthesia Inhalation
- Device Class
- Class II
- Regulation Number
- 868.5330
- Review Panel
- AN
- Submission Type