510(k) K131877
K131877 is an FDA 510(k) premarket notification submitted by Automedx, Inc. for the device "SAVE II, SAVE II BASIC". The FDA issued a decision of Substantially Equivalent on March 21, 2014. The device falls under product code BTL (Ventilator, Emergency, Powered (Resuscitator)), a Class II device regulated under 21 CFR 868.5925. Automedx, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 21, 2014
- Date Received
- June 25, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ventilator, Emergency, Powered (Resuscitator)
- Device Class
- Class II
- Regulation Number
- 868.5925
- Review Panel
- AN
- Submission Type