510(k) K171411
K171411 is an FDA 510(k) premarket notification submitted by A.R Guide IN Medical , Ltd. for the device "IRRIS (Infra-Red-Red Intubation System)". The FDA issued a decision of Substantially Equivalent on Jan 12, 2018. The device falls under product code BTR (Tube, Tracheal (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5730.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 12, 2018
- Date Received
- May 15, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tube, Tracheal (W/Wo Connector)
- Device Class
- Class II
- Regulation Number
- 868.5730
- Review Panel
- AN
- Submission Type
- 510(k)