510(k) K150900
K150900 is an FDA 510(k) premarket notification submitted by Flexicare Medical, Ltd. for the device "Flexicare Heated Wire Breathing Systems". The FDA issued a decision of Substantially Equivalent on May 15, 2015. 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. Flexicare Medical, Ltd. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 15, 2015
- Date Received
- April 3, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
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