SERIES 50 XMO (MODEL M1350C) FETAL/MATERNAL MONITOR SYSTEM WITH INTEGRATED FETAL OXYGEN SATURATION MONITORING
FDA premarket approval P020028 · decided 2003-01-03
Approval details
- 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.
- Date received
- 2002-07-09
- Decision date
- 2003-01-03
- Days to decision
- 178 days
- Decision code
- APWD
- Product code
- MMA
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Andover, MA
- Statement
- APPROVAL FOR THE SERIES 50 XMO (MODEL M1350C) FETAL/MATERNAL MONITOR SYSTEM WITH INTEGRATED FETAL OXYGEN SATURATION MONITORING, M1365A FETAL SPO2 PATIENT MODULE, AND THE NELLCOR OXIFIRST FS14 SENSOR. THIS DEVICE IS INTENDED FOR CONTINUOUS MONITORING OF INTRAPARTUM FETAL OXYGEN SATURATION (FSPO2) AND THE FSPO2 PARAMETER IS INDICATED AS AN ADJUNCT TO FETAL HEART RATE (FHR) MONITORING IN THE PRESENCE OF A NONREASSURING FETAL HEART RATE PATTERN. IT SHOULD ONLY BE USED AFTER AMNIOTIC MEMBRANES HAVE R
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| PCR ELEVA 1.2 (K093355) | Philips Medical Systems, Inc. | 2010-01-08 |
| PINNACLE3 SMARTARC (K090808) | Philips Medical Systems, Inc. | 2009-04-03 |
| PHILIPS HEARTSTART 12 LEAD TRANSFER STATION, MODEL 989803142521 (K071391) | Philips Medical Systems, Inc. | 2007-09-07 |
| PHILIPS REUSABLE SPO2 SENSORS M1191T, M1192T AND M1193T, CLIP SENSOR M1196T AND DISPOSABLE SPO2 SENSORS M1131A, M1132A (K063783) | Philips Medical Systems, Inc. | 2007-04-27 |
| M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE F.0 AND M4840A PHILIPS TELEMETRY SYSTEM II INCLUDING M4841A PATIEN (K041741) | Philips Medical Systems, Inc. | 2004-07-21 |
| M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE E.01 AND INTELLIVUE CLINICAL NETWORK ON VLAN (K040955) | Philips Medical Systems, Inc. | 2004-05-12 |
| HEARTSTART MRX, MODEL M3535A (K040404) | Philips Medical Systems, Inc. | 2004-05-04 |
| M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE F.O AND THE M4840A TELEMETRY MONITORING SYSTEM II (K040357) | Philips Medical Systems, Inc. | 2004-03-03 |