PMA
P000016: COROMETRICS 120F SERIES MATERNAL/FETAL MONITOR
FDA PMA · Oximeter, fetal pulse · Ge Medical Systems Information Technologies
Key facts
| PMA number | P000016 |
|---|---|
| Trade name | COROMETRICS 120F SERIES MATERNAL/FETAL MONITOR |
| Generic name | Oximeter, fetal pulse |
| Applicant | Ge Medical Systems Information Technologies |
| Owner/operator | GE HealthCare Technologies Inc. |
| Product code | MMA |
| Approval date | Feb 9, 2001 |
| Docket number | 01M-0329 |
| Notice date | Aug 2, 2001 |
| Establishment registration | 3001570235 |
| FEI number | 3001570235 |
At a glance
- 1–9 Supplements
- Oct 15, 2003 Latest supplement decision
- Yes Withdrawn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: