BigEasy Non-Rebreathing Valve
FDA 510(k) clearance K142402 · decided 2015-03-23
Clearance details
- K-number
- K142402
- Device name
- BigEasy Non-Rebreathing Valve
- Applicant
- 12th Man Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-08-27
- Decision date
- 2015-03-23
- Days to decision
- 208 days
- Clearance type
- Traditional
- Product code
- CBP
- Device class
- 2
- Regulation number
- 868.5870
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Garden Grove, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.