PMA P890057S022

Device
3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV)
Applicant
ZOLL Medical Corporation
PMA number
P890057
Supplement
S022
Product code
LSZ
Decision date
2014-06-02
Classification
Ventilator, High Frequency
Generic name
VENTILATOR, HIGH FREQUENCY
Approval order statement
CHANGE TO THE DIAPHRAGM CAP ASSEMBLY.

Current openFDA PMA Record#

Device
3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV)
Applicant
ZOLL Medical Corporation
PMA number
P890057
Supplement
S022
Product code
LSZ
Generic name
VENTILATOR, HIGH FREQUENCY
Decision date
2014-06-02
Decision code
OK30
Date received
2014-04-29
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
CHANGE TO THE DIAPHRAGM CAP ASSEMBLY.