ReDe Mask
FDA 510(k) clearance K161953 · decided 2017-02-17
Clearance details
- K-number
- K161953
- Device name
- ReDe Mask
- Applicant
- Tereopneuma
- Decision
- Substantially Equivalent
- Date received
- 2016-07-18
- Decision date
- 2017-02-17
- Days to decision
- 214 days
- Clearance type
- Traditional
- Product code
- PRK
- Device class
- 2
- Regulation number
- 868.2375
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.