PMA
P890057: MODEL 3100 FREQUENCY OSCILLATORY VENTILATOR
FDA PMA · VENTILATOR, HIGH FREQUENCY · ZOLL Medical Corporation
Key facts
| PMA number | P890057 |
|---|---|
| Trade name | MODEL 3100 FREQUENCY OSCILLATORY VENTILATOR |
| Generic name | VENTILATOR, HIGH FREQUENCY |
| Applicant | ZOLL Medical Corporation |
| Owner/operator | ZOLL Medical Corporation |
| Product code | LSZ |
| Approval date | Mar 29, 1991 |
| Docket number | 91M-0142 |
| Notice date | Apr 25, 1991 |
| Establishment registration | 1220908 |
| FEI number | 1220908 |
At a glance
- 10–99 Supplements
- Jul 23, 2025 Latest supplement decision
- No Withdrawn
- No Summary of safety and effectiveness on file
- 10–99 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: