510(k) K922821

YSI MODELS 4700 FOLEY CATHETER TEMPERATURE PROBES by Yellow Springs Instrument Co., Inc. — Product Code EZL

K922821 is an FDA 510(k) premarket notification submitted by Yellow Springs Instrument Co., Inc. for the device "YSI MODELS 4700 FOLEY CATHETER TEMPERATURE PROBES". The FDA issued a decision of Substantially Equivalent on November 23, 1992. The device falls under product code EZL (Catheter, Retention Type, Balloon), a Class II device regulated under 21 CFR 876.5130. Yellow Springs Instrument Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 23, 1992
Date Received
June 11, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Retention Type, Balloon
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type