PMA
P980010: DTU-ONE ULTRASOUND SCANNER
FDA PMA · Bone sonometer · Osteometer Meditech A/S
Key facts
| PMA number | P980010 |
|---|---|
| Trade name | DTU-ONE ULTRASOUND SCANNER |
| Generic name | Bone sonometer |
| Applicant | Osteometer Meditech A/S |
| Owner/operator | Meditech International Inc |
| Product code | MUA |
| Approval date | Sep 19, 2000 |
| Docket number | 00M-1615 |
| Notice date | Nov 15, 2000 |
| Establishment registration | 3003082988 |
| FEI number | 3003082988 |
At a glance
- None Supplements
- Sep 19, 2000 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- No Withdrawn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: