RESQCPR SYSTEM
FDA premarket approval P110024/S001 · decided 2015-06-15
Approval details
- PMA number
- P110024
- Supplement
- S001
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- RESQCPR SYSTEM
- Generic name
- Combination compression/decompression manual chest pump with impedance respiratory valve
- Applicant
- ZOLL Medical Corporation
- Date received
- 2015-05-12
- Decision date
- 2015-06-15
- Days to decision
- 34 days
- Decision code
- APPR
- Product code
- PIZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Chelsmford, MA
- Statement
- APPROVAL FOR A MODIFICATION TO THE TIMING LIGHT SWITCH EXTENSION ON THE RESQPOD ITD 16.
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