MODEL 3100 FREQUENCY OSCILLATORY VENTILATOR
FDA premarket approval P890057 · decided 1991-03-29
Approval details
- PMA number
- P890057
- Trade name
- MODEL 3100 FREQUENCY OSCILLATORY VENTILATOR
- Generic name
- VENTILATOR, HIGH FREQUENCY
- Applicant
- ZOLL Medical Corporation
- Date received
- 1989-10-04
- Decision date
- 1991-03-29
- Days to decision
- 541 days
- Decision code
- APPR
- Product code
- LSZ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Chelsmford, MA
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510(k) clearances by this applicant
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| ZOLL Propaq M (K180482) | ZOLL Medical Corporation | 2018-11-30 |
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| 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 |