510(k) K943761
K943761 is an FDA 510(k) premarket notification submitted by Rondex Products, Inc. for the device "NON-BREATHING VALVE". The FDA issued a decision of Substantially Equivalent (kit) on November 10, 1994. The device falls under product code CBP (Valve, Non-Rebreathing), a Class II device regulated under 21 CFR 868.5870. Rondex Products, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESK (Substantially Equivalent (kit))
- Decision Date
- November 10, 1994
- Date Received
- August 2, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Valve, Non-Rebreathing
- Device Class
- Class II
- Regulation Number
- 868.5870
- Review Panel
- AN
- Submission Type