PMA P110024S003

Device
ResQCPR System
Applicant
ZOLL Medical Corporation
PMA number
P110024
Supplement
S003
Product code
PIZ
Decision date
2021-11-17
Generic name
Combination compression/decompression manual chest pump with impedance respiratory valve
Approval order statement
Approval for a texture on the sealing surface of the ResQPOD ITD 16 diaphragm, a component of the ResQCPR System.

Current openFDA PMA Record#

Device
ResQCPR System
Applicant
ZOLL Medical Corporation
PMA number
P110024
Supplement
S003
Product code
PIZ
Generic name
Combination compression/decompression manual chest pump with impedance respiratory valve
Decision date
2021-11-17
Decision code
APPR
Date received
2021-08-25
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for a texture on the sealing surface of the ResQPOD ITD 16 diaphragm, a component of the ResQCPR System.