510(k) K823232

YSI #2650 SINGLE-DISPLAY OXYGEN & TEMP by Yellow Springs Instrument Co., Inc. — Product Code CCL

K823232 is an FDA 510(k) premarket notification submitted by Yellow Springs Instrument Co., Inc. for the device "YSI #2650 SINGLE-DISPLAY OXYGEN & TEMP". The FDA issued a decision of Substantially Equivalent on December 7, 1982. The device falls under product code CCL (Analyzer, Gas, Oxygen, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1720. Yellow Springs Instrument Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 7, 1982
Date Received
October 29, 1982
Clearance Type
Traditional
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