510(k) DEN000004
DEN000004 is an FDA 510(k) premarket notification submitted by Maet Industries, Inc. for the device "QUICKAIR CHOKE RELIEVER, MODEL 59-001A". The FDA issued a decision of De Novo Granted on February 29, 2000. The device falls under product code MZT (Device, Heimlich Maneuver Assist), a Class II device regulated under 21 CFR 868.5115.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- February 29, 2000
- Date Received
- January 28, 2000
- Clearance Type
- Post-NSE
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Heimlich Maneuver Assist
- Device Class
- Class II
- Regulation Number
- 868.5115
- Review Panel
- AN
- Submission Type