510(k) K163464
K163464 is an FDA 510(k) premarket notification submitted by Bmc Medical., Ltd. for the device "Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2)". The FDA issued a decision of Substantially Equivalent on Sep 5, 2017. The device falls under product code BZD (Ventilator, Non-Continuous (Respirator)), a Class II device regulated under 21 CFR 868.5905.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 5, 2017
- Date Received
- Dec 9, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ventilator, Non-Continuous (Respirator)
- Device Class
- Class II
- Regulation Number
- 868.5905
- Review Panel
- AN
- Submission Type
- 510(k)