510(k) K791713

VICKERS MEDICAL MODEL 130 NEAVENT-NEO by Vickers America Medical Corp. — Product Code CBK

K791713 is an FDA 510(k) premarket notification submitted by Vickers America Medical Corp. for the device "VICKERS MEDICAL MODEL 130 NEAVENT-NEO". The FDA issued a decision of Substantially Equivalent on September 19, 1979. The device falls under product code CBK (Ventilator, Continuous, Facility Use), a Class II device regulated under 21 CFR 868.5895. Vickers America Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 1979
Date Received
August 27, 1979
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