510(k) K221477
K221477 is an FDA 510(k) premarket notification submitted by Hospitech Respiration , Ltd. for the device "AG100s". The FDA issued a decision of Substantially Equivalent on December 29, 2022. The device falls under product code BSK (Cuff, Tracheal Tube, Inflatable), a Class II device regulated under 21 CFR 868.5750. Hospitech Respiration , Ltd. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 29, 2022
- Date Received
- May 23, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cuff, Tracheal Tube, Inflatable
- Device Class
- Class II
- Regulation Number
- 868.5750
- Review Panel
- AN
- Submission Type