510(k) K840925
K840925 is an FDA 510(k) premarket notification submitted by Intl. Medical Devices , Ltd. for the device "PEDIA-TRAKE CRICOTHYROTOMY KIT". The FDA issued a decision of Substantially Equivalent on May 2, 1984. The device falls under product code BTO (Tube, Tracheostomy (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5800. Intl. Medical Devices , Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 2, 1984
- Date Received
- March 2, 1984
- 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