510(k) K822812

YSI MODEL 23L LACTATE ANALYZER by Yellow Springs Instrument Co., Inc. — Product Code HHP

K822812 is an FDA 510(k) premarket notification submitted by Yellow Springs Instrument Co., Inc. for the device "YSI MODEL 23L LACTATE ANALYZER". The FDA issued a decision of Substantially Equivalent on December 13, 1982. The device falls under product code HHP (Table, Obstetrical, Manual (And Accessories)), a Class II device regulated under 21 CFR 884.4900. Yellow Springs Instrument Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 1982
Date Received
September 20, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Obstetrical, Manual (And Accessories)
Device Class
Class II
Regulation Number
884.4900
Review Panel
OB
Submission Type