510(k) K925438
K925438 is an FDA 510(k) premarket notification submitted by Aga Medical Products, Inc. for the device "COMBINATION TRACH TIE & VENTILATOR ANTIDISCONNECT". The FDA issued a decision of Substantially Equivalent on February 17, 1993. The device falls under product code JOH (Tube Tracheostomy And Tube Cuff), a Class II device regulated under 21 CFR 868.5800. Aga Medical Products, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 17, 1993
- Date Received
- October 28, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tube Tracheostomy And Tube Cuff
- Device Class
- Class II
- Regulation Number
- 868.5800
- Review Panel
- AN
- Submission Type