510(k) K173205
K173205 is an FDA 510(k) premarket notification submitted by O-Two Medical Technologies, Inc. for the device "Equinox Advantage". The FDA issued a decision of Substantially Equivalent on August 29, 2018. 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
- August 29, 2018
- Date Received
- October 2, 2017
- 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