PMA P890057S010

Device
MODEL 3100A HIGH FREQUENCY OCILLATORY VENTILATOR
Applicant
ZOLL Medical Corporation
PMA number
P890057
Supplement
S010
Product code
LSZ
Decision date
1998-06-15
Classification
Ventilator, High Frequency
Generic name
VENTILATOR, HIGH FREQUENCY
Approval order statement
Approval for changes to the oscillating mechanism and an increased range of continuous flow.

Current openFDA PMA Record#

Device
MODEL 3100A HIGH FREQUENCY OCILLATORY VENTILATOR
Applicant
ZOLL Medical Corporation
PMA number
P890057
Supplement
S010
Product code
LSZ
Generic name
VENTILATOR, HIGH FREQUENCY
Decision date
1998-06-15
Decision code
APPR
Date received
1997-07-03
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for changes to the oscillating mechanism and an increased range of continuous flow.