| Device Type ID | 3953 |
| Device Name | System, Monitoring, Perinatal |
| Regulation Description | Perinatal Monitoring System And Accessories. |
| Regulation Medical Specialty | Obstetrics/Gynecology |
| Review Panel | Obstetrics/Gynecology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Obstetrics And Gynecology Devices Branch (OGDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 884.2740 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | HGM |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 3953 |
| Device | System, Monitoring, Perinatal |
| Product Code | HGM |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Perinatal Monitoring System And Accessories. |
| CFR Regulation Number | 884.2740 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ADVANCED INSTRUMENTATIONS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ALERTWATCH, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BISTOS CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
EDAN INSTRUMENTS INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
EDAN INSTRUMENTS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
GUANGDONG BIOLIGHT MEDITECH CO., LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GUANGDONG BIOLIGHT MEDITECH CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HUNTLEIGH HEALTHCARE LIMITED | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MINDCHILD MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
OB TOOLS, LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PHILIPS MEDICAL SYSTEMS | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
PHILIPS MEDIZIN SYSTEME BOBLINGEN GMBH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Defective Device | 10 |
Device Operates Differently Than Expected | 5 |
Adverse Event Without Identified Device Or Use Problem | 3 |
Electrode | 3 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 2 |
Device Alarm System | 2 |
Out-Of-Box Failure | 2 |
Incorrect Interpretation Of Signal | 1 |
Loose Or Intermittent Connection | 1 |
Incorrect Or Inadequate Test Results | 1 |
Insufficient Information | 1 |
No Audible Alarm | 1 |
Appropriate Term/Code Not Available | 1 |
Device Displays Incorrect Message | 1 |
False Positive Result | 1 |
Fire | 1 |
| Total Device Problems | 36 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Philips Medical Systems, Inc. | II | Oct-21-2014 |