OJR215 Pressure Relief Manifold— 510(k) K173770
Substantially EquivalentFisher & Paykel Healthcare Limited
FDA 510(k) clearance K173770 for OJR215 Pressure Relief Manifold, Substantially Equivalent on 2019-04-05. Applicant: Fisher & Paykel Healthcare Limited. Device class: 2.
Clearance details
- Applicant
- Fisher & Paykel Healthcare Limited
- Product code
- Code CBP
- Device class
- Class 2
- Regulation
- 21 CFR 868.5870
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Auckland, NZ
Recent devices under product code CBP
view all- K241366 — QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV)
- K234053 — F&P Optiflow Flow Diverter
- K210992 — Altech® Exhalation Valve (Single Limb and Dual Limb)
- K192285 — CPR Face Shield
- K171961 — Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compower Infant CPR Mask, Compower Non-Rebreathing Valve (22mm/15mmOD), Non-Rebreathing Valve (22mm/18.5mm)
More clearances from Fisher & Paykel Healthcare Limited
view allData sourced from openFDA. This site is unofficial and independent of the FDA.