PMA
P000055: UBIS 5000 BONE SONOMETER
FDA PMA · Bone sonometer · Diagnostic Medical Systems
Key facts
| PMA number | P000055 |
|---|---|
| Trade name | UBIS 5000 BONE SONOMETER |
| Generic name | Bone sonometer |
| Applicant | Diagnostic Medical Systems |
| Product code | MUA |
| Approval date | Jul 17, 2001 |
| Docket number | 01M-0360 |
| Notice date | Aug 23, 2001 |
| FEI number | 3003081145 |
At a glance
- None Supplements
- Jul 17, 2001 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- None 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: