510(k) K113687
K113687 is an FDA 510(k) premarket notification submitted by O-Two Medical Technologies, Inc. for the device "EQUINOX RELIEVE". The FDA issued a decision of Substantially Equivalent on April 30, 2012. The device falls under product code BZR (Mixer, Breathing Gases, Anesthesia Inhalation), a Class II device regulated under 21 CFR 868.5330. O-Two Medical Technologies, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 30, 2012
- Date Received
- December 15, 2011
- 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