RESPOND(R) Ventilator
FDA 510(k) clearance K241135 · decided 2024-11-13
Clearance details
- K-number
- K241135
- Device name
- RESPOND(R) Ventilator
- Applicant
- Corvent Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2024-04-24
- Decision date
- 2024-11-13
- Days to decision
- 203 days
- Clearance type
- Traditional
- Product code
- CBK
- Device class
- 2
- Regulation number
- 868.5895
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Fargo, ND, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Corvent Medical
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.