510(k) K924373

ACCUFLATE ACCESSORIE CART W/IV POLE AND CLAMP by Instrumed, Inc. — Product Code BZN

K924373 is an FDA 510(k) premarket notification submitted by Instrumed, Inc. for the device "ACCUFLATE ACCESSORIE CART W/IV POLE AND CLAMP". The FDA issued a decision of Substantially Equivalent on November 25, 1992. The device falls under product code BZN (Cart, Emergency, Cardiopulmonary (Excluding Equipment)), a Class I device regulated under 21 CFR 868.6175. Instrumed, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 25, 1992
Date Received
August 28, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cart, Emergency, Cardiopulmonary (Excluding Equipment)
Device Class
Class I
Regulation Number
868.6175
Review Panel
AN
Submission Type