MODEL 3100A HIGH FREQUENCY OCILLATORY VENTILATOR
FDA premarket approval P890057/S005 · decided 1995-03-23
Approval details
- PMA number
- P890057
- Supplement
- S005
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MODEL 3100A HIGH FREQUENCY OCILLATORY VENTILATOR
- Generic name
- VENTILATOR, HIGH FREQUENCY
- Applicant
- ZOLL Medical Corporation
- Date received
- 1993-03-15
- Decision date
- 1995-03-23
- Days to decision
- 738 days
- Decision code
- APPR
- Product code
- LSZ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Chelsmford, MA
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 |