MODEL 3100B HIGH-FREQUENCY OSCILLATORY VENTILATORY (HFOV)
FDA premarket approval P890057/S018 · decided 2005-03-10
Approval details
- PMA number
- P890057
- Supplement
- S018
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MODEL 3100B HIGH-FREQUENCY OSCILLATORY VENTILATORY (HFOV)
- Generic name
- VENTILATOR, HIGH FREQUENCY
- Applicant
- ZOLL Medical Corporation
- Date received
- 2004-12-20
- Decision date
- 2005-03-10
- Days to decision
- 80 days
- Decision code
- APPR
- Product code
- LSZ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Chelsmford, MA
- Statement
- APPROVAL FOR MODIFICATIONS TO THE HEAT AND FILTER ON THE EXHALED GAS LIMB OF THE EXISTING PATIENT CIRCUIT.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| 731 Series Ventilator (K233486) | ZOLL Medical Corporation | 2024-12-13 |
| ZOLL Propaq M (K202375) | ZOLL Medical Corporation | 2021-03-09 |
| 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 |