Unipor Breathing Circuit Filter

• • Terminated Z-2038-2014 FDA Class II ·initiated 4 Jun 2014

  Possible leak from the filter allowing a small of amount of air to be released from the junction between the filter end cap (flat side of the filter) and the filter housing connection.

510(k) Number

K791307 ↗

FDA Product Code

CAH

Device Class

Class II

Regulation

21 CFR Part 868.5260

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

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See all devices from Pall Biomedical Products Co. →