510(k) K923834
K923834 is an FDA 510(k) premarket notification submitted by American Healthcare Corp. for the device "TRACHEOSTOMY CARE SET WITH GLOVES". The FDA issued a decision of Substantially Equivalent (kit) on December 10, 1992. The device falls under product code BTO (Tube, Tracheostomy (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5800. American Healthcare Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESK (Substantially Equivalent (kit))
- Decision Date
- December 10, 1992
- Date Received
- July 31, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tube, Tracheostomy (W/Wo Connector)
- Device Class
- Class II
- Regulation Number
- 868.5800
- Review Panel
- AN
- Submission Type