CAREvent MRI 01CV7000
by O-Two Medical Technologies Inc
CAREvent MRI 01CV7000 is a Class II device made by O-Two Medical Technologies Inc, cleared under FDA 510(k) K051469 on 28 Sep 2005 and listed in FDA GUDID since 23 Oct 2015 (UDI-DI 07540195030183), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number07540195030183 | Date23 Oct 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK051469 | Date28 Sep 2005 | StatusActive |
Official records
- AccessGUDID record 07540195030183
- FDA 510(k) database K051469
Across registries
- FDA 510(k) K051469 decided 28 Sep 2005 Active
- FDA GUDID UDI-DI 07540195030183 listed 23 Oct 2015 Listed
Timeline
- Cleared FDA 510(k) K051469
- Listed FDA GUDID 07540195030183
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- CAREvent MRI
- Generic name
- Portable pneumatic ventilator
- Model / Ref / Catalog
- 01CV7000
- Primary DI / UDI-DI
- 07540195030183
- 510(k) Number
- FDA product code
- BTL
- GMDN term
- Portable pneumatic ventilator
- Device class
- Class II
- Regulation number
- 868.5925
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
- Size
- Weight — 6.25 PoundHeight — 4.3 InchWidth — 6.5 InchLength — 9.25 Inch
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