PMA
P000041: RAPIDSCREEN RS-2000
FDA PMA · Analyzer, medical image · Riverain Medical Group
Key facts
| PMA number | P000041 |
|---|---|
| Trade name | RAPIDSCREEN RS-2000 |
| Generic name | Analyzer, medical image |
| Applicant | Riverain Medical Group |
| Owner/operator | MEDICALGROUP |
| Product code | MYN |
| Approval date | Jul 12, 2001 |
| Docket number | 01M-0306 |
| Notice date | Jul 23, 2001 |
| Establishment registration | 3007051929 |
| FEI number | 3007051929 |
At a glance
- 1–9 Supplements
- Feb 27, 2012 Latest supplement decision
- No Withdrawn
- Yes 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: