510(k) K202831
K202831 is an FDA 510(k) premarket notification submitted by Pac-Dent, Inc. for the device "The iMask Child's Face Mask". The FDA issued a decision of Substantially Equivalent on August 26, 2021. The device falls under product code OXZ (Pediatric/Child Facemask), a Class II device regulated under 21 CFR 878.4040. Pac-Dent, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 26, 2021
- Date Received
- September 25, 2020
- 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.