FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
CAREVENT ATV+ AND CAREVENT MRI
K Number: K051469
·
Decision Sep 28, 2005
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
99
Applicant Total
8
Review Days
117
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Basic Information
- Device Name
- CAREVENT ATV+ AND CAREVENT MRI
- K Number
- K051469
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5925
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- O-Two Medical Technologies, Inc.
- Date Received
- June 3, 2005
- Decision Date
- September 28, 2005
- Product Code
- BTL
- 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 |
|---|---|---|---|
| BTL | Ventilator, Emergency, Powered (Resuscitator) | FDA class 2 | Anesthesiology |
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Other Clearances by O-Two Medical Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K173205 | Equinox Advantage | Aug 29, 2018 | Substantially Equivalent |
| 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 |
| K051889 | CAREVENT CA AND DRA | Aug 30, 2005 | Substantially Equivalent |