510(k) K160100
K160100 is an FDA 510(k) premarket notification submitted by Prestige Ameritech for the device "Prestige Ameritech Pediatric/Childs Face mask". The FDA issued a decision of Substantially Equivalent on October 7, 2016. The device falls under product code OXZ (Pediatric/Child Facemask), a Class II device regulated under 21 CFR 878.4040. Prestige Ameritech has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 7, 2016
- Date Received
- January 19, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pediatric/Child Facemask
- Device Class
- Class II
- Regulation Number
- 878.4040
- Review Panel
- HO
- Submission Type
A pediatric/child facemask is intended to be worn by the patient/child to provide protection for the respiratory tract. It is a single use, disposable device that is provided non-sterile. The facemask is recommended for use in a healthcare setting with appropriate adult supervision.