510(k) K100104
K100104 is an FDA 510(k) premarket notification submitted by Plastiflex Group NV for the device "HYBERNITE RAINOUT CONTROL SYSTEM". The FDA issued a decision of Substantially Equivalent on April 14, 2010. The device falls under product code BZE (Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer), a Class II device regulated under 21 CFR 868.5270. Plastiflex Group NV has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 14, 2010
- Date Received
- January 13, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
- Device Class
- Class II
- Regulation Number
- 868.5270
- Review Panel
- AN
- Submission Type