510(k) K211949
K211949 is an FDA 510(k) premarket notification submitted by Airstrip Technologies, Inc. for the device "AirStrip ONE Web Client with Alarm Communication Management (ACM)". The FDA issued a decision of Substantially Equivalent on December 9, 2021. The device falls under product code MSX (System, Network And Communication, Physiological Monitors), a Class II device regulated under 21 CFR 870.2300. Airstrip Technologies, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 9, 2021
- Date Received
- June 23, 2021
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Network And Communication, Physiological Monitors
- Device Class
- Class II
- Regulation Number
- 870.2300
- Review Panel
- CV
- Submission Type