Nurture Rest
FDA 510(k) clearance K172962 · decided 2018-01-18
Clearance details
- K-number
- K172962
- Device name
- Nurture Rest
- Applicant
- Neonatal Loving Kare, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2017-09-26
- Decision date
- 2018-01-18
- Days to decision
- 114 days
- Clearance type
- Traditional
- Product code
- OUW
- Device class
- 1
- Regulation number
- 880.5680
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Dubois, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.