PMA
P990035: THE SUNLIGHT OMNISENSE(TM) ULTRASOUND BONE SONOMETER
FDA PMA · Bone sonometer · Beam-Med, Ltd.
Key facts
| PMA number | P990035 |
|---|---|
| Trade name | THE SUNLIGHT OMNISENSE(TM) ULTRASOUND BONE SONOMETER |
| Generic name | Bone sonometer |
| Applicant | Beam-Med, Ltd. |
| Owner/operator | MED INTERNATIONAL INC |
| Product code | MUA |
| Approval date | Jan 20, 2000 |
| Docket number | 00M-0577 |
| Notice date | Feb 16, 2000 |
| Establishment registration | 3030531253 |
| FEI number | 3030531253 |
At a glance
- 1–9 Supplements
- Nov 17, 2003 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 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: