Walk-O2-Bout
FDA 510(k) clearance K161472 · decided 2016-11-18
Clearance details
- K-number
- K161472
- Device name
- Walk-O2-Bout
- Applicant
- Essex Industries, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2016-05-27
- Decision date
- 2016-11-18
- Days to decision
- 175 days
- Clearance type
- Traditional
- Product code
- ECX
- Device class
- 1
- Regulation number
- 868.2700
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- St. Louis, MO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.