PMA
P850064: MODEL 203 LIFE PULSE HIGH FREQUENCY VENTILATOR
FDA PMA · VENTILATOR, HIGH FREQUENCY · Bunnell, Inc.
Key facts
| PMA number | P850064 |
|---|---|
| Trade name | MODEL 203 LIFE PULSE HIGH FREQUENCY VENTILATOR |
| Generic name | VENTILATOR, HIGH FREQUENCY |
| Applicant | Bunnell, Inc. |
| Owner/operator | BUNNELL INCORPORATED |
| Product code | LSZ |
| Approval date | Jun 30, 1988 |
| Docket number | 88M-0263 |
| Notice date | Aug 10, 1988 |
| Establishment registration | 3032745446 |
| FEI number | 3032745446 |
At a glance
- 10–99 Supplements
- Sep 28, 2026 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- No Withdrawn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: