HIGH FREQUENCY OSCILLATING VENTILATOR
FDA premarket approval P890057/S020 · decided 2012-01-31
Approval details
- PMA number
- P890057
- Supplement
- S020
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- HIGH FREQUENCY OSCILLATING VENTILATOR
- Generic name
- VENTILATOR, HIGH FREQUENCY
- Applicant
- ZOLL Medical Corporation
- Date received
- 2011-12-01
- Decision date
- 2012-01-31
- Days to decision
- 61 days
- Decision code
- APPR
- Product code
- LSZ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Chelsmford, MA
- Statement
- APPROVAL FOR THE ADDITION OF AN ADHESIVE TO THE WELDED JOINTS OF THE BREATHING CIRCUIT HUB IN THE DEVICE.
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