510(k) K881178
K881178 is an FDA 510(k) premarket notification submitted by Dhd Medical Products Div. Diemolding Corp. for the device "CUFFCHECK". The FDA issued a decision of Substantially Equivalent on April 14, 1988. The device falls under product code BSK (Cuff, Tracheal Tube, Inflatable), a Class II device regulated under 21 CFR 868.5750. Dhd Medical Products Div. Diemolding Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 14, 1988
- Date Received
- March 18, 1988
- 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