RESQCPR SYSTEM
FDA premarket approval P110024 · decided 2015-03-06
Approval details
- PMA number
- P110024
- Trade name
- RESQCPR SYSTEM
- Generic name
- Combination compression/decompression manual chest pump with impedance respiratory valve
- Applicant
- ZOLL Medical Corporation
- Date received
- 2011-06-15
- Decision date
- 2015-03-06
- Days to decision
- 1360 days
- Decision code
- APPR
- Product code
- PIZ
- Advisory committee
- Cardiovascular
- Expedited review
- Yes
- Location
- Chelsmford, MA
- Statement
- APPROVAL FOR THE RESQCPR SYSTEM. THIS DEVICE IS INDICATED FOR USE AS A CPR ADJUNCT TO IMPROVE THE LIKELIHOOD OF SURVIVAL IN ADULT PATIENTS WITH NON-TRAUMATIC CARDIAC ARREST.
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