510(k) K900236
K900236 is an FDA 510(k) premarket notification submitted by Ventlab Corp. for the device "ET-RESTRAINT CAT. # ER 4000". The FDA issued a decision of Substantially Equivalent on February 2, 1990. The device falls under product code CBH (Device, Fixation, Tracheal Tube), a Class I device regulated under 21 CFR 868.5770. Ventlab Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 2, 1990
- Date Received
- January 17, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Fixation, Tracheal Tube
- Device Class
- Class I
- Regulation Number
- 868.5770
- Review Panel
- AN
- Submission Type