PMA
P020028: SERIES 50 XMO (MODEL M1350C) FETAL/MATERNAL MONITOR SYSTEM WITH INTEGRATED FETAL OXYGEN SATURATION MONITORING
FDA PMA · Oximeter, fetal pulse · Philips Medical Systems, Inc.
Key facts
| PMA number | P020028 |
|---|---|
| Trade name | SERIES 50 XMO (MODEL M1350C) FETAL/MATERNAL MONITOR SYSTEM WITH INTEGRATED FETAL OXYGEN SATURATION MONITORING |
| Generic name | Oximeter, fetal pulse |
| Applicant | Philips Medical Systems, Inc. |
| Owner/operator | Philips Medical Systems International BV |
| Product code | MMA |
| Approval date | Jan 3, 2003 |
| Docket number | 03M-0241 |
| Notice date | Jun 25, 2003 |
| Establishment registration | 1218950 |
| FEI number | 1218950 |
At a glance
- None Supplements
- Jan 3, 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- Yes Withdrawn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: