510(k) K173807

Accu O2 Oxygen Analyzer by Precision Medical, Inc. — Product Code CCL

K173807 is an FDA 510(k) premarket notification submitted by Precision Medical, Inc. for the device "Accu O2 Oxygen Analyzer". The FDA issued a decision of Substantially Equivalent on May 2, 2018. The device falls under product code CCL (Analyzer, Gas, Oxygen, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1720. Precision Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 2018
Date Received
December 15, 2017
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Gas, Oxygen, Gaseous-Phase
Device Class
Class II
Regulation Number
868.1720
Review Panel
AN
Submission Type