510(k) K122432
K122432 is an FDA 510(k) premarket notification submitted by Fisher & Paykel Healthcare, Ltd. for the device "ADULT EVAQUA 2' DUAL HEATED BREATHING CIRCUITS". The FDA issued a decision of Substantially Equivalent on December 6, 2012. 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. Fisher & Paykel Healthcare, Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 6, 2012
- Date Received
- August 10, 2012
- 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