510(k) K840356

OHIO UNITROL II ANESTHESIA GAS MACHINE by Ohio Medical Products — Product Code BSZ

K840356 is an FDA 510(k) premarket notification submitted by Ohio Medical Products for the device "OHIO UNITROL II ANESTHESIA GAS MACHINE". The FDA issued a decision of Substantially Equivalent on April 20, 1984. The device falls under product code BSZ (Gas-Machine, Anesthesia), a Class II device regulated under 21 CFR 868.5160. Ohio Medical Products has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 1984
Date Received
January 26, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gas-Machine, Anesthesia
Device Class
Class II
Regulation Number
868.5160
Review Panel
AN
Submission Type