Guidance for Oxygen Conserving Device 510(k) Review 73 BZD 868.5905 Non-continuous Ventilator Class II February 1989
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Guidance Issuing OfficeCenter for Devices and Radiological Health
This guide provides information about device specifications, criteria, and labeling.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
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All written comments should be identified with this document's docket number: FDA-2020-D-0957.