510(k) K221841
K221841 is an FDA 510(k) premarket notification submitted by Archeon for the device "EOlife®". The FDA issued a decision of Substantially Equivalent on Mar 18, 2023. The device falls under product code BTM (Ventilator, Emergency, Manual (Resuscitator)), a Class II device regulated under 21 CFR 868.5915.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 18, 2023
- Date Received
- Jun 24, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ventilator, Emergency, Manual (Resuscitator)
- Device Class
- Class II
- Regulation Number
- 868.5915
- Review Panel
- AN
- Submission Type