3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV)
FDA premarket approval P890057/S022 · decided 2014-06-02
Approval details
- PMA number
- P890057
- Supplement
- S022
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV)
- Generic name
- VENTILATOR, HIGH FREQUENCY
- Applicant
- ZOLL Medical Corporation
- Date received
- 2014-04-29
- Decision date
- 2014-06-02
- Days to decision
- 34 days
- Decision code
- OK30
- Product code
- LSZ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Chelsmford, MA
- Statement
- CHANGE TO THE DIAPHRAGM CAP ASSEMBLY.
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