510(k) K241465

Midas Flowmeter; eAVS by Parker Hannifin Corporation — Product Code BZR

K241465 is an FDA 510(k) premarket notification submitted by Parker Hannifin Corporation for the device "Midas Flowmeter; eAVS". The FDA issued a decision of Substantially Equivalent on September 19, 2024. The device falls under product code BZR (Mixer, Breathing Gases, Anesthesia Inhalation), a Class II device regulated under 21 CFR 868.5330. Parker Hannifin Corporation has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 2024
Date Received
May 23, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mixer, Breathing Gases, Anesthesia Inhalation
Device Class
Class II
Regulation Number
868.5330
Review Panel
AN
Submission Type