510(k) K833335

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

K833335 is an FDA 510(k) premarket notification submitted by Ohio Medical Products for the device "MODULUS II ANESTHESIA GAS MACHINE". The FDA issued a decision of Substantially Equivalent on November 14, 1983. 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
November 14, 1983
Date Received
September 27, 1983
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