FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
Equinox Advantage
K Number: K173205
·
Decision Aug 29, 2018
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
54
Applicant Total
8
Review Days
331
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Basic Information
- Device Name
- Equinox Advantage
- K Number
- K173205
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5330
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- O-Two Medical Technologies, Inc.
- Date Received
- October 2, 2017
- Decision Date
- August 29, 2018
- Product Code
- BZR
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| BZR | Mixer, Breathing Gases, Anesthesia Inhalation | FDA class 2 | Anesthesiology |
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Other Clearances by O-Two Medical Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K141595 | O-TWO E700,O-TWO E600,O-TWO E500 | Mar 16, 2015 | Substantially Equivalent |
| K113687 | EQUINOX RELIEVE | Apr 30, 2012 | Substantially Equivalent |
| K112546 | O_TWO CPAP SYSTEM | Dec 27, 2011 | Substantially Equivalent |
| K093862 | CAREVENT HANDHELD CPAP SYSTEM | May 6, 2010 | Substantially Equivalent |
| K081330 | CAREVENT PAR (PUBLIC ACCESS RESUSCITATOR) | Mar 6, 2009 | Substantially Equivalent |
| K051469 | CAREVENT ATV+ AND CAREVENT MRI | Sep 28, 2005 | Substantially Equivalent |
| K051889 | CAREVENT CA AND DRA | Aug 30, 2005 | Substantially Equivalent |