510(k) K942628
K942628 is an FDA 510(k) premarket notification submitted by Wolfe Tory Medical, Inc. for the device "ESOPHAGEAL INTUBATION DETECTOR BULB". The FDA issued a decision of Substantially Equivalent on August 18, 1994. The device falls under product code BTR (Tube, Tracheal (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5730. Wolfe Tory Medical, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 18, 1994
- Date Received
- June 2, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tube, Tracheal (W/Wo Connector)
- Device Class
- Class II
- Regulation Number
- 868.5730
- Review Panel
- AN
- Submission Type