510(k) K973755
K973755 is an FDA 510(k) premarket notification submitted by Instrumentation Industries, Inc. for the device "PILOT TUBE REPAIR KIT". The FDA issued a decision of Substantially Equivalent on December 17, 1997. The device falls under product code BSK (Cuff, Tracheal Tube, Inflatable), a Class II device regulated under 21 CFR 868.5750. Instrumentation Industries, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 17, 1997
- Date Received
- October 2, 1997
- 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