510(k) K821376

OHIO 7000 ELECTRONIC ANESTHESIA VENTIL. by Ohio Medical Products — Product Code CBK

K821376 is an FDA 510(k) premarket notification submitted by Ohio Medical Products for the device "OHIO 7000 ELECTRONIC ANESTHESIA VENTIL.". The FDA issued a decision of Substantially Equivalent on June 29, 1982. The device falls under product code CBK (Ventilator, Continuous, Facility Use), a Class II device regulated under 21 CFR 868.5895. Ohio Medical Products has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 29, 1982
Date Received
May 10, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Continuous, Facility Use
Device Class
Class II
Regulation Number
868.5895
Review Panel
AN
Submission Type