3100 High Frequency Oscillating Ventilator (HFOV), Vyaire Model 31008 Oscillatory Ventilator
FDA premarket approval P890057/S027 · decided 2024-11-15
Approval details
- PMA number
- P890057
- Supplement
- S027
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- 3100 High Frequency Oscillating Ventilator (HFOV), Vyaire Model 31008 Oscillatory Ventilator
- Generic name
- VENTILATOR, HIGH FREQUENCY
- Applicant
- ZOLL Medical Corporation
- Date received
- 2023-07-03
- Decision date
- 2024-11-15
- Days to decision
- 501 days
- Decision code
- APPR
- Product code
- LSZ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Chelsmford, MA
- Statement
- The material change made to a component on 3100 HFOV pressure sense line as part of the patient circuit has been reviewed and is acceptable.
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510(k) clearances by this applicant
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| 731 Series Ventilator (K233486) | ZOLL Medical Corporation | 2024-12-13 |
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| ZOLL Propaq M (K180482) | ZOLL Medical Corporation | 2018-11-30 |
| Power Infuser (K172653) | ZOLL Medical Corporation | 2018-07-18 |
| 731 Series Ventilators (K162832) | ZOLL Medical Corporation | 2017-08-02 |
| Model 330 Multifunction Aspirator (K170533) | ZOLL Medical Corporation | 2017-04-18 |
| ZOLL X Series (K142915) | ZOLL Medical Corporation | 2014-12-03 |
| ZOLL X SERIES (K141774) | ZOLL Medical Corporation | 2014-11-19 |