FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CAREVENT PAR (PUBLIC ACCESS RESUSCITATOR)
K Number: K081330
·
Decision Mar 6, 2009
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
99
Applicant Total
8
Review Days
298
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- CAREVENT PAR (PUBLIC ACCESS RESUSCITATOR)
- K Number
- K081330
- 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
- May 12, 2008
- Decision Date
- March 6, 2009
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BTL), ordered by most recent decision date.
VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031)
FDA 510(k)
FDA Class 2
·Anesthesiology
Oxymag - Transport and Emergency Ventilator
FDA 510(k)
FDA Class 2
·Anesthesiology
VORTRAN GO2VENT with PEEP Valve
FDA 510(k)
FDA Class 2
·Anesthesiology
MEDUMAT Easy CPR, MEDUMAT Easy CPR with bag
FDA 510(k)
FDA Class 2
·Anesthesiology
Puffin Lite Infant Resuscitation System
FDA 510(k)
FDA Class 2
·Anesthesiology
SafeT T-Piece Resuscitator
FDA 510(k)
FDA Class 2
·Anesthesiology
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 |
| K051469 | CAREVENT ATV+ AND CAREVENT MRI | Sep 28, 2005 | Substantially Equivalent |
| K051889 | CAREVENT CA AND DRA | Aug 30, 2005 | Substantially Equivalent |