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Miscellaneous
Subpart B—Clinical Chemistry Test Systems
CFR Sub-Part
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart B—Obstetrical and Gynecological Diagnostic Devices
CFR Sub-Part
Subpart C—Cardiovascular Monitoring Devices
CFR Sub-Part
Subpart C—Obstetrical and Gynecological Monitoring Devices
CFR Sub-Part
HEQ
Monitor, Pressure, Arterial, Fetal, Ultrasonic
2
Product Code
HEI
Monitor, Heart-Valve Movement, Fetal, Ultrasonic
2
Product Code
HEJ
Monitor, Hemic Sound, Ultrasonic
2
Product Code
HEK
Monitor, Heart Sound, Fetal, Ultrasonic
2
Product Code
HEL
Monitor, Heart Rate, Fetal, Ultrasonic
2
Product Code
HEM
Imager, Ultrasonic Obstetric-Gynecologic
2
Product Code
HEN
Caliper, Fetal Head, Ultrasonic
2
Product Code
HEO
Analyzer, Data, Obstetric
3
Product Code
HEP
Monitor, Blood-Flow, Ultrasonic
2
Product Code
HFM
Monitor, Uterine Contraction, External (For Use In Clinic)
2
Product Code
HFN
Transducer, Pressure, Intrauterine
2
Product Code
HFO
Recorder, Pressure, Intrauterine
2
Product Code
HFP
Monitor, Phonocardiographic, Fetal
2
Product Code
HGL
Transducer, Ultrasonic, Obstetric
2
Product Code
HGM
System, Monitoring, Perinatal
2
Product Code
K
23
3440
Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch (989803196341)
2
Cleared 510(K)
K
23
1964
Novii+ Wireless Patch System
2
Cleared 510(K)
K
22
2327
Bloomlife MFM-Pro
2
Cleared 510(K)
K
22
0732
Mural Perinatal Surveillance
2
Cleared 510(K)
K
20
0975
Sonicaid Team3 Antepartum, Sonicaid Team3 Intrapartum
2
Cleared 510(K)
K
17
3941
IntelliSpace Perinatal Rev.K.00
2
Cleared 510(K)
K
17
3042
Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models F2, F3
2
Cleared 510(K)
K
17
3715
AlertWatch:OB
2
Cleared 510(K)
K
17
1178
Central Monitoring System
2
Cleared 510(K)
K
17
1865
F1 Mothership Wireless Transducers for Fetal Ultrasonic and Tocodynamometer Monitoring
2
Cleared 510(K)
K
16
1902
Meridian M110 Fetal Monitoring System
2
Cleared 510(K)
K
15
3580
Central Monitoring System
2
Cleared 510(K)
K
15
0398
EUM 100Pro
2
Cleared 510(K)
K
14
2799
Model BT-220L and BT-220C
2
Cleared 510(K)
K
15
0901
Fetal & Maternal Monitor, models F6, F6 Express, F9, F9 Express
2
Cleared 510(K)
K
14
2883
MindChild Meridian M100 Fetal Heart Rate Monitor
2
Cleared 510(K)
K
14
3695
CENTRAL MONITORING SYSTEM
2
Cleared 510(K)
K
14
0535
PHILIPS AVALON FETAL / MATERNAL MONITORS FM20, FM30, FM40 AND FM50
2
Cleared 510(K)
K
14
1194
FM-3000 FETAL MONITOR
2
Cleared 510(K)
K
13
1941
FETAL MONITORS
2
Cleared 510(K)
K
13
2650
SONICAID FREEDOM WIRELESS FETAL MONITORING SYSTEM
2
Cleared 510(K)
K
13
2918
SENSE-4BABY SYSTEM
2
Cleared 510(K)
K
12
3335
SUNRAY FETAL MONITOR
2
Cleared 510(K)
K
12
1758
CERNER FETALINK+(VERSION1.0)
2
Cleared 510(K)
K
12
0018
MINDCHILD MERIDIAN FETAL HEART RATE MONITOR
2
Cleared 510(K)
K
12
1267
BT-200V VASCULAR DOPPLER
2
Cleared 510(K)
K
12
1208
OBIX PERINATAL DATA SYSTEM 7.0
2
Cleared 510(K)
K
11
2317
FM-9000 PLUS FETAL AND MATERNAL MONITOR
2
Cleared 510(K)
K
11
0612
FM20
2
Cleared 510(K)
K
11
1614
CENTRICITY PERINATAL AND CENTRICITY INTENSIVE CARE
2
Cleared 510(K)
K
11
2187
FM-1000 PLUS FETAL MONITOR
2
Cleared 510(K)
K
11
2159
CMS-1000FM CENTRAL MONITORING SYSTEM
2
Cleared 510(K)
K
11
1083
PHILIPS AVALON FETAL/MATERNAL MONITORS FM20, FM30, FM40 AND FM50
2
Cleared 510(K)
K
11
0556
MINI TELEMETRY SYSTEM
2
Cleared 510(K)
K
10
3545
BT-350
2
Cleared 510(K)
K
10
2263
HORIZON PERINATAL CARE SURVEILLANCE AND ARCHIVAL MODEL VERSON 4.0
2
Cleared 510(K)
K
10
2958
PHILIPS AVALON FETAL MONITOR
2
Cleared 510(K)
K
10
3172
CIV-OB (PLUS)
2
Cleared 510(K)
K
10
2140
FETAL MONITORS, MODELS F2 AND F3
2
Cleared 510(K)
K
10
0358
CENTRAL MONITORING SYSTEM
2
Cleared 510(K)
K
10
0797
FETAL MATERNAL MONITOR MODEL F9 EXPRESS AND EXPRESS
2
Cleared 510(K)
K
10
0420
PHILIPS OBTRACEVUE MODEL SW REV. G.00
2
Cleared 510(K)
K
10
0885
FETAL MONITOR MODEL: BT-200T
2
Cleared 510(K)
K
09
2028
PHILIPS AVALON FETAL MONITORS FM20, FM30, FM40, AND FM50
2
Cleared 510(K)
K
09
1251
CERNER FETALINK (VERSION 1.0)
2
Cleared 510(K)
K
09
0285
SONICAID FM820 AND FM830 ENCORE
2
Cleared 510(K)
K
09
0269
AIRSTRIP OB
2
Cleared 510(K)
K
09
0061
AIRSTRIP OB
2
Cleared 510(K)
K
08
2602
FETAL & MATERNAL MONITOR, MODEL F6, F9
2
Cleared 510(K)
K
08
2369
CADENCE, CADENCE DUAL, CADENCE II FETAL MONITOR
2
Cleared 510(K)
K
08
1203
OB TRACEVUE OBSTETRICAL INFORMATION MANAGEMENT SYSTEM WITH RELEASE F.00
2
Cleared 510(K)
K
08
0226
NAVICARE -WATCHCHILD OBSTETRICAL DATA MANAGEMENT SYSTEM (NAVICARE -WATCHCHILD), MODEL P2912
2
Cleared 510(K)
K
07
3221
CADENCE II
2
Cleared 510(K)
K
07
2976
MODEL 250CX SERIES MATERNAL/FETAL MONITOR
2
Cleared 510(K)
K
07
1800
PHILIPS AVALON FETAL MONITORS FM20 AND FM30
2
Cleared 510(K)
K
06
2137
MODIFICATION TO PHILIPS AVALON FETAL MONITORS FM20 AND FM30
2
Cleared 510(K)
K
05
0826
FETAL ULTRASOUND AND TOCODYNAMOMETER TRANSDUCERS
2
Cleared 510(K)
K
06
0230
DOPPLEX CENTRALE
2
Cleared 510(K)
K
05
1175
CIV-OB OBSTRICAL MONITORING SOFTWARE APPLICATION
2
Cleared 510(K)
K
05
2795
PHILIPS AVALON FETAL MONITOR, MODELS FM20 AND FM30
2
Cleared 510(K)
K
05
2715
CALM CURVE, VERSION 01.00
2
Cleared 510(K)
K
04
3597
FC 700 FETAL MONITOR
2
Cleared 510(K)
K
04
3598
FC 1400 FETAL MONITOR
2
Cleared 510(K)
K
05
2190
FETAL MONITOR, MODELS BT-300 AND BT-200
2
Cleared 510(K)
K
05
0234
REMOTE CARE
2
Cleared 510(K)
K
04
3075
TENACORE TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING
2
Cleared 510(K)
K
05
0583
MODEL 250 SERIES MATERNAL/FETAL MONITOR
2
Cleared 510(K)
K
04
0788
CALM PATTERNS, VERSION 01.00.00
2
Cleared 510(K)
K
04
2082
AIRSTRIP OB
2
Cleared 510(K)
K
04
0903
CADENCE, MODELS 2001 AND 2002
2
Cleared 510(K)
K
04
0819
TRANSDUCER FOR ULTRASOUND FETAL MONITORING, MODELS FM10833 AND FM10834
2
Cleared 510(K)
K
03
2772
MODIFICATION TO WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT SYSTEM (ALSO REFERRED TO AS) THE WATCHCHILD SYSTEM
2
Cleared 510(K)
K
03
2252
MODEL 120 SERIES MATERNAL/FETAL MONITOR
2
Cleared 510(K)
K
03
0261
BATTERY, RECHARGEABLE
2
Cleared 510(K)
K
02
3931
PHILIPS AVALON CTS CORDLESS FETAL TRANSDUCER SYSTEM, MODELS M2720A, M2725A, M2726A, M2727A
2
Cleared 510(K)
K
02
3618
SONICAID ONE
2
Cleared 510(K)
K
02
1574
TM2000 FETALTRACE TRANSTELEPHONIC RECEIVING CENTER
2
Cleared 510(K)
K
02
1135
MODEL 2120IS SERIES MATERNAL/FETAL MONITOR
2
Cleared 510(K)
K
01
3281
VERSALAB APM
2
Cleared 510(K)
K
01
4094
MODIFICATION TO THE WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT SYSTEM
2
Cleared 510(K)
K
01
2718
MODIFICATION TO COROMETRICS MODEL 120IS MATERNAL/FETAL MONITORING SYSTEM.
2
Cleared 510(K)
K
01
1304
OB-1 FETAL MONITOR
2
Cleared 510(K)
K
01
0552
CG-900P FETAL/MATERNAL MONITOR
2
Cleared 510(K)
K
99
2607
SONICAID SYSTEM 8002
2
Cleared 510(K)
K
01
0889
BABY DOPPLEX 3000 MK 2 (BD3000)
2
Cleared 510(K)
K
01
0894
BABY DOPPLEX 3002 (BD3002)
2
Cleared 510(K)
K
00
2150
SONICAID FM820, SONICAID FM830
2
Cleared 510(K)
K
00
2548
FETAL ASSIST
2
Cleared 510(K)
K
00
2503
FETALGARD LITE
2
Cleared 510(K)
K
99
4008
BIOSYS FETAL MONITOR, MODEL IFM-500
2
Cleared 510(K)
K
00
1882
BABY DOPPLEX 4002-TWINS, MODEL BD4002
2
Cleared 510(K)
K
00
1677
BABY DOPPLEX 4000 (BD4000)
2
Cleared 510(K)
K
99
3751
COROMETRICS MODEL 173 FETAL MONITOR
2
Cleared 510(K)
K
99
0569
BABY DOPPLEX 4000, MODEL BD 4000
2
Cleared 510(K)
K
99
3008
QUANTITATIVE SENTINEL SYSTEM
2
Cleared 510(K)
K
99
1905
COROMETRICS MODEL 171 AND 172 FETAL MONITOR
2
Cleared 510(K)
K
99
1739
COROMETRICS 120 SERIES MATERNAL/FETAL MONITOR
2
Cleared 510(K)
K
98
3395
FETALGARD 3000 FETAL MONITOR
2
Cleared 510(K)
K
97
4248
WATCHCHILD OBSTERICAL PATIENT DATA MANAGEMENT SYSTEM
2
Cleared 510(K)
K
98
0719
CALM
2
Cleared 510(K)
K
96
5008
BIRTHNET II PERINATAL PATIENT DATA MANAGEMENT SYSTEM
2
Cleared 510(K)
K
97
0456
HEWLETT APCKARD SERIES 50 OB TRACEVUE OBSTETRICAL SURVEILLANCE AND ARCHIVING SYSTEM
2
Cleared 510(K)
K
96
3711
BABY DOPPLEX (3000)
2
Cleared 510(K)
K
97
1099
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS5169
2
Cleared 510(K)
K
96
0553
CARD GUARD MODEL CG-900
2
Cleared 510(K)
K
96
3608
QUANTITATIVE SENTINEL SYSTEM
2
Cleared 510(K)
K
96
4770
COROMETRICS 120 SERIES MATERNAL/FETAL MONITOR
2
Cleared 510(K)
K
95
5931
MODEL IM77 INTRAPARTUM FETAL MONITOR (MODIFICATION)
2
Cleared 510(K)
K
96
0109
QUANTITATIVE SENTINEL SYSTEM
2
Cleared 510(K)
K
95
4351
SERIES 50XM
2
Cleared 510(K)
K
95
5559
COROMETRICS FETAL MOVEMENT DETECTION KIT
2
Cleared 510(K)
K
95
0420
FETALGARD 3000 - MODELS IP1, IP2, AP2 AND AP3
2
Cleared 510(K)
K
93
1133
CLINICAL INFOR SYST(CIS) W/FETAL MONIT REMOTE DISP
2
Cleared 510(K)
K
94
0898
MODEL IM77 INTRAPARTUM FETAL MONITOR
2
Cleared 510(K)
K
93
5377
R AND D BATTERIES
2
Cleared 510(K)
K
93
5301
R & D BATTERIES, INC. PART NUMBERS 5235, 5506 & 5050
2
Cleared 510(K)
K
94
2887
MODEL M1310A, SERIES 50T FETAL TELEMETRY SYSTEM
2
Cleared 510(K)
K
93
4959
MODEL 118 FETAL/MATERNAL MONITOR
2
Cleared 510(K)
K
93
2077
MODEL 151 FETAL MONITOR
2
Cleared 510(K)
K
92
5572
MITYVAC DISPOS-A-PLATE DISPOSABLE LEG PLATE
2
Cleared 510(K)
K
92
1956
HEWLETT PACKARD MODEL M1353A FETAL MONITOR
2
Cleared 510(K)
K
92
1957
HEWLETT-PACKARD MODEL M1351A FETAL MONITOR
2
Cleared 510(K)
K
92
0376
COROMETRICS MODEL 150 FETAL MONITOR
2
Cleared 510(K)
K
91
2138
HOMEVUE MONITORING SYS.MODEL TD 2000
2
Cleared 510(K)
K
91
2890
MODEL SONICAID AXIS
2
Cleared 510(K)
K
91
2639
SONICAID TEAM
2
Cleared 510(K)
K
91
0169
FETALGARD 2000
2
Cleared 510(K)
K
91
0418
LIFE-TRACE DISPOSABLE LEG PLATE PRODUCT # LT-100
2
Cleared 510(K)
K
91
0260
COROMETRICS MDL 330 FETAL/MATERNAL TELEMETRY SYST
2
Cleared 510(K)
K
90
5606
EXTERNAL FETAL MONITOR TRANSDUCER HOLDER
2
Cleared 510(K)
K
90
5295
CATALOG NUMBER 2609 LEG PLATE
2
Cleared 510(K)
K
90
2690
SONICAID MODEL MERIDIAN 800
2
Cleared 510(K)
K
90
3992
CYGNET CENTRAL
2
Cleared 510(K)
K
90
4358
MODEL 855 ENHANCED PERFORMANCE REMOTE TERMINAL
2
Cleared 510(K)
K
90
2802
FETAL MONITORING TRANSDUCER STRAP
2
Cleared 510(K)
K
90
0480
M1350A FETAL MONITOR (INTRAPARTUM)
2
Cleared 510(K)
K
89
3981
WATCHCHILD
2
Cleared 510(K)
K
89
5045
MODEL 410T TELECOMMUNICATION SYSTEM
2
Cleared 510(K)
K
89
4036
TOITU FETAL ACTOCARDIOGRAPH, MT-332
2
Cleared 510(K)
K
89
4958
MODEL 410 ALERT AND TELECOMMUNICATION SYSTEM
2
Cleared 510(K)
K
89
2501
WRIGHT MEDICAL FETASAFE
2
Cleared 510(K)
K
89
2354
ODIS - OBSTETRICAL DISPLAY INFO SYSTEM, HP M1370A
2
Cleared 510(K)
K
89
1595
MODEL 116 FETAL MONITOR
2
Cleared 510(K)
K
88
2084
GENESIS TM FETAL SYSTEM
2
Cleared 510(K)
K
88
2966
MODEL 320 FETAL/MATERNAL TELEMETRY SYSTEM
2
Cleared 510(K)
K
88
0419
MODEL 800 O.B. DATA ARCHIVAL SYSTEM
2
Cleared 510(K)
K
87
1082
FETAL CARE MONITOR ANTEPARTUM 1500
2
Cleared 510(K)
K
87
1383
FETALERT ADR FETAL MONITOR
2
Cleared 510(K)
K
87
1385
MODEL U-1000 WITH GESTATIONAL AGE CALCULATION
2
Cleared 510(K)
K
87
0692
PERINATAL COMPUTERS 2015/2025/2040/2045/2080/2085
2
Cleared 510(K)
K
86
0237
OMF-7101 FETAL MONITOR
2
Cleared 510(K)
K
86
1544
MODEL 80225A OBSTETRICAL MANAGEMENT SYSTEM
2
Cleared 510(K)
K
86
1556
MODIFIED FETAL MONITOR MODEL FM-2
2
Cleared 510(K)
K
86
1455
MODEL DT-102 DATA TELEPHONE TRANSMITTER
2
Cleared 510(K)
K
86
0295
FETASCAN 1500
2
Cleared 510(K)
K
86
1189
TECNOL SECURE-ALL FETAL MONITOR STRAP
2
Cleared 510(K)
K
85
5044
PERINATAL COMPUTER SYS MODEL 100A & 100B
2
Cleared 510(K)
K
85
2704
TWEETHEART #102 FETAL/NEONATAL HEARTBEAT ANNUNCIAT
2
Cleared 510(K)
K
85
2608
SPECTRA 400 EXTENDED SURVEILLANCE & ALERT SYSTEM
2
Cleared 510(K)
K
84
2422
KONTRON FAX FETAL MONITOR
2
Cleared 510(K)
K
85
2518
MODIFICATION FETAL MONITOR MODEL FM-2
2
Cleared 510(K)
K
85
2076
MODEL 145 FETAL MONITOR
2
Cleared 510(K)
K
85
1252
COROMETRICS 115 FETAL MONITOR W/DUAL CARDIOTACHOME
2
Cleared 510(K)
K
84
4724
FETAL TELEMETRY SYSTEM
2
Cleared 510(K)
K
84
3918
COROMETRICS FETAL MONITOR 142
2
Cleared 510(K)
K
84
3385
COROMETRICS 115 FETAL MONITOR
2
Cleared 510(K)
K
84
1477
COROMETRICS 815 FETAL ECG RECORDER
2
Cleared 510(K)
K
83
2849
FETAL MONITOR #FM-2
2
Cleared 510(K)
K
83
1114
EPCOM EMS-330 FREEDOM I TELEDOP OBSTET
2
Cleared 510(K)
K
83
1113
EPCOM EMS-310 INTRAPARTUM MONITOR
2
Cleared 510(K)
K
83
1115
EPCOM EMS-320 REMOTE MONITORSCOPE
2
Cleared 510(K)
K
83
1852
FETAL MONITOR #115
2
Cleared 510(K)
K
83
1371
MODEL FM5
2
Cleared 510(K)
K
82
3188
M2000 INTRAPARTUM FETAL MONITOR
2
Cleared 510(K)
K
82
3081
M2100 ANTEPARTUM FETAL MONITOR
2
Cleared 510(K)
K
82
2830
MEDICAL LABS FETAL SCAN #1000 W/CENTRAL
2
Cleared 510(K)
K
82
1478
TELEPHONE LINK DATA TRANSMISSION SYS
2
Cleared 510(K)
K
82
1580
FETAL MONITOR #FM 750
2
Cleared 510(K)
K
82
1479
CENTRAL DISPLAY SYSTEM #CS400
2
Cleared 510(K)
K
81
3457
FETASCAN 2000,2000A OBSTETRICAL DATA
2
Cleared 510(K)
K
81
3458
FETASCAN 1000, 1000A OBSTETRICAL DATA
2
Cleared 510(K)
K
81
3007
EPCOM EMS-180 ANTEPARTUM FETAL MONITOR
2
Cleared 510(K)
K
81
2863
FETASONDE 5, #30, CENTRAL NURSING STAT
2
Cleared 510(K)
K
81
2256
MODEL AP 180 MINI-MONITOR
2
Cleared 510(K)
K
80
1747
TERUMO FETAL MONITOR # FHM-602
2
Cleared 510(K)
K
80
0013
FETAL MONITOR MODEL FHM-1
2
Cleared 510(K)
K
79
1039
FETASONDE FETAL HEART RATE VARIABILITY
2
Cleared 510(K)
K
79
1037
FETASONDE LABOR STATUS DISPLAY
2
Cleared 510(K)
K
79
1036
FETASONDE UTERINE WORK MONITOR
2
Cleared 510(K)
K
79
1035
FETASONDE FETAL ACTIVITY MONITOR
2
Cleared 510(K)
K
79
1038
FETASONDE UTERINE ACTIVITY MONITOR
2
Cleared 510(K)
K
79
0761
FETASONDE MODEL 2108
2
Cleared 510(K)
K
79
0139
MONITOR, OFFICE MODEL 140
2
Cleared 510(K)
K
78
1359
MODEL 80032A, OBSTETRICAL TELEMETRY
2
Cleared 510(K)
K
78
1360
MODEL 80100A, PATIENT DATA MEMORY
2
Cleared 510(K)
K
78
0177
FETAL MONITOR MODEL 112
2
Cleared 510(K)
K
78
0176
DISPLAY SYSTEM MODEL 428
2
Cleared 510(K)
K
77
1541
FETAL MONITORING SYSTEM
2
Cleared 510(K)
K
77
1379
FETAL MONITORING SYS. MODEL FM3R
2
Cleared 510(K)
K
77
1194
FETAL/MATERNAL ALRM MODULE - 21595A
2
Cleared 510(K)
K
77
1196
MARKER GENERATOR MODULES - 21597A
2
Cleared 510(K)
K
77
1195
FETAL/MATERNAL REPEATER - 21596A
2
Cleared 510(K)
K
77
0692
MONITOR, FETAL, NO. L04-1100
2
Cleared 510(K)
K
77
0297
FETAL MONITOR, PART #100-11009
2
Cleared 510(K)
K
77
0296
FETAL MONITOR, PART #101-11009
2
Cleared 510(K)
K
76
1201
ECHO-CARDIOTRACE, AUTOMATIC
2
Cleared 510(K)
K
76
1139
T-M (TIME-MOTION) OPTION
2
Cleared 510(K)
K
76
1030
EKOSECTOR I
2
Cleared 510(K)
K
76
0919
MODEL 2106 FETA SONDE FETAL MONITOR
2
Cleared 510(K)
HGN
Stethoscope, Fetal
1
Product Code
HGO
Monitor, Electroencephalographic, Fetal (And Accessories)
3
Product Code
HGP
Electrode, Circular (Spiral), Scalp And Applicator
2
Product Code
HGS
Catheter, Intrauterine And Introducer
2
Product Code
HHJ
Locator, Intracorporeal Device, Ultrasonic, Obstetric-Gynecologic
2
Product Code
HHX
Holograph, Fetal, Acoustical
2
Product Code
HIQ
Electrode, Clip, Fetal Scalp (And Applicator)
3
Product Code
KNG
Monitor, Ultrasonic, Fetal
2
Product Code
KXN
Monitor, Cardiac, Fetal
2
Product Code
KXO
Monitor, Pressure, Intrauterine
2
Product Code
LQK
Home Uterine Activity Monitor
2
Product Code
MOH
Monitor, Heart Rate, Fetal, Non-Stress Test (Home Use)
2
Product Code
NHM
Sheet, Recording, Breast Examination
2
Product Code
NKA
System, Documentation, Breast Lesion
2
Product Code
OSP
Uterine Electromyographic Monitor
2
Product Code
NPB
System, Monitoring, For Progress Of Labor
2
Product Code
Subpart D—Cardiovascular Prosthetic Devices
CFR Sub-Part
Subpart D—Obstetrical and Gynecological Prosthetic Devices
CFR Sub-Part
Subpart D—Physical Medicine Prosthetic Devices
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—Obstetrical and Gynecological Surgical Devices
CFR Sub-Part
Subpart F—Obstetrical and Gynecological Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Subpart G—Assisted Reproduction Devices
CFR Sub-Part
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 30 November 2024 at 11:09 am
OB
/
subpart-c—obstetrical-and-gynecological-monitoring-devices
/
HGM
/
K102140
View Source
FETAL MONITORS, MODELS F2 AND F3
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K102140
510(k) Type
Traditional
Applicant
EDAN INSTRUMENTS, INC.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
1/13/2011
Days to Decision
168 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Miscellaneous
Subpart B—Clinical Chemistry Test Systems
Subpart B—Diagnostic Devices
Subpart B—Obstetrical and Gynecological Diagnostic Devices
Subpart C—Cardiovascular Monitoring Devices
Subpart C—Obstetrical and Gynecological Monitoring Devices
HEQ
Monitor, Pressure, Arterial, Fetal, Ultrasonic
HEI
Monitor, Heart-Valve Movement, Fetal, Ultrasonic
HEJ
Monitor, Hemic Sound, Ultrasonic
HEK
Monitor, Heart Sound, Fetal, Ultrasonic
HEL
Monitor, Heart Rate, Fetal, Ultrasonic
HEM
Imager, Ultrasonic Obstetric-Gynecologic
HEN
Caliper, Fetal Head, Ultrasonic
HEO
Analyzer, Data, Obstetric
HEP
Monitor, Blood-Flow, Ultrasonic
HFM
Monitor, Uterine Contraction, External (For Use In Clinic)
HFN
Transducer, Pressure, Intrauterine
HFO
Recorder, Pressure, Intrauterine
HFP
Monitor, Phonocardiographic, Fetal
HGL
Transducer, Ultrasonic, Obstetric
HGM
System, Monitoring, Perinatal
K
23
3440
Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch (989803196341)
K
23
1964
Novii+ Wireless Patch System
K
22
2327
Bloomlife MFM-Pro
K
22
0732
Mural Perinatal Surveillance
K
20
0975
Sonicaid Team3 Antepartum, Sonicaid Team3 Intrapartum
K
17
3941
IntelliSpace Perinatal Rev.K.00
K
17
3042
Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models F2, F3
K
17
3715
AlertWatch:OB
K
17
1178
Central Monitoring System
K
17
1865
F1 Mothership Wireless Transducers for Fetal Ultrasonic and Tocodynamometer Monitoring
K
16
1902
Meridian M110 Fetal Monitoring System
K
15
3580
Central Monitoring System
K
15
0398
EUM 100Pro
K
14
2799
Model BT-220L and BT-220C
K
15
0901
Fetal & Maternal Monitor, models F6, F6 Express, F9, F9 Express
K
14
2883
MindChild Meridian M100 Fetal Heart Rate Monitor
K
14
3695
CENTRAL MONITORING SYSTEM
K
14
0535
PHILIPS AVALON FETAL / MATERNAL MONITORS FM20, FM30, FM40 AND FM50
K
14
1194
FM-3000 FETAL MONITOR
K
13
1941
FETAL MONITORS
K
13
2650
SONICAID FREEDOM WIRELESS FETAL MONITORING SYSTEM
K
13
2918
SENSE-4BABY SYSTEM
K
12
3335
SUNRAY FETAL MONITOR
K
12
1758
CERNER FETALINK+(VERSION1.0)
K
12
0018
MINDCHILD MERIDIAN FETAL HEART RATE MONITOR
K
12
1267
BT-200V VASCULAR DOPPLER
K
12
1208
OBIX PERINATAL DATA SYSTEM 7.0
K
11
2317
FM-9000 PLUS FETAL AND MATERNAL MONITOR
K
11
0612
FM20
K
11
1614
CENTRICITY PERINATAL AND CENTRICITY INTENSIVE CARE
K
11
2187
FM-1000 PLUS FETAL MONITOR
K
11
2159
CMS-1000FM CENTRAL MONITORING SYSTEM
K
11
1083
PHILIPS AVALON FETAL/MATERNAL MONITORS FM20, FM30, FM40 AND FM50
K
11
0556
MINI TELEMETRY SYSTEM
K
10
3545
BT-350
K
10
2263
HORIZON PERINATAL CARE SURVEILLANCE AND ARCHIVAL MODEL VERSON 4.0
K
10
2958
PHILIPS AVALON FETAL MONITOR
K
10
3172
CIV-OB (PLUS)
K
10
2140
FETAL MONITORS, MODELS F2 AND F3
K
10
0358
CENTRAL MONITORING SYSTEM
K
10
0797
FETAL MATERNAL MONITOR MODEL F9 EXPRESS AND EXPRESS
K
10
0420
PHILIPS OBTRACEVUE MODEL SW REV. G.00
K
10
0885
FETAL MONITOR MODEL: BT-200T
K
09
2028
PHILIPS AVALON FETAL MONITORS FM20, FM30, FM40, AND FM50
K
09
1251
CERNER FETALINK (VERSION 1.0)
K
09
0285
SONICAID FM820 AND FM830 ENCORE
K
09
0269
AIRSTRIP OB
K
09
0061
AIRSTRIP OB
K
08
2602
FETAL & MATERNAL MONITOR, MODEL F6, F9
K
08
2369
CADENCE, CADENCE DUAL, CADENCE II FETAL MONITOR
K
08
1203
OB TRACEVUE OBSTETRICAL INFORMATION MANAGEMENT SYSTEM WITH RELEASE F.00
K
08
0226
NAVICARE -WATCHCHILD OBSTETRICAL DATA MANAGEMENT SYSTEM (NAVICARE -WATCHCHILD), MODEL P2912
K
07
3221
CADENCE II
K
07
2976
MODEL 250CX SERIES MATERNAL/FETAL MONITOR
K
07
1800
PHILIPS AVALON FETAL MONITORS FM20 AND FM30
K
06
2137
MODIFICATION TO PHILIPS AVALON FETAL MONITORS FM20 AND FM30
K
05
0826
FETAL ULTRASOUND AND TOCODYNAMOMETER TRANSDUCERS
K
06
0230
DOPPLEX CENTRALE
K
05
1175
CIV-OB OBSTRICAL MONITORING SOFTWARE APPLICATION
K
05
2795
PHILIPS AVALON FETAL MONITOR, MODELS FM20 AND FM30
K
05
2715
CALM CURVE, VERSION 01.00
K
04
3597
FC 700 FETAL MONITOR
K
04
3598
FC 1400 FETAL MONITOR
K
05
2190
FETAL MONITOR, MODELS BT-300 AND BT-200
K
05
0234
REMOTE CARE
K
04
3075
TENACORE TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING
K
05
0583
MODEL 250 SERIES MATERNAL/FETAL MONITOR
K
04
0788
CALM PATTERNS, VERSION 01.00.00
K
04
2082
AIRSTRIP OB
K
04
0903
CADENCE, MODELS 2001 AND 2002
K
04
0819
TRANSDUCER FOR ULTRASOUND FETAL MONITORING, MODELS FM10833 AND FM10834
K
03
2772
MODIFICATION TO WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT SYSTEM (ALSO REFERRED TO AS) THE WATCHCHILD SYSTEM
K
03
2252
MODEL 120 SERIES MATERNAL/FETAL MONITOR
K
03
0261
BATTERY, RECHARGEABLE
K
02
3931
PHILIPS AVALON CTS CORDLESS FETAL TRANSDUCER SYSTEM, MODELS M2720A, M2725A, M2726A, M2727A
K
02
3618
SONICAID ONE
K
02
1574
TM2000 FETALTRACE TRANSTELEPHONIC RECEIVING CENTER
K
02
1135
MODEL 2120IS SERIES MATERNAL/FETAL MONITOR
K
01
3281
VERSALAB APM
K
01
4094
MODIFICATION TO THE WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT SYSTEM
K
01
2718
MODIFICATION TO COROMETRICS MODEL 120IS MATERNAL/FETAL MONITORING SYSTEM.
K
01
1304
OB-1 FETAL MONITOR
K
01
0552
CG-900P FETAL/MATERNAL MONITOR
K
99
2607
SONICAID SYSTEM 8002
K
01
0889
BABY DOPPLEX 3000 MK 2 (BD3000)
K
01
0894
BABY DOPPLEX 3002 (BD3002)
K
00
2150
SONICAID FM820, SONICAID FM830
K
00
2548
FETAL ASSIST
K
00
2503
FETALGARD LITE
K
99
4008
BIOSYS FETAL MONITOR, MODEL IFM-500
K
00
1882
BABY DOPPLEX 4002-TWINS, MODEL BD4002
K
00
1677
BABY DOPPLEX 4000 (BD4000)
K
99
3751
COROMETRICS MODEL 173 FETAL MONITOR
K
99
0569
BABY DOPPLEX 4000, MODEL BD 4000
K
99
3008
QUANTITATIVE SENTINEL SYSTEM
K
99
1905
COROMETRICS MODEL 171 AND 172 FETAL MONITOR
K
99
1739
COROMETRICS 120 SERIES MATERNAL/FETAL MONITOR
K
98
3395
FETALGARD 3000 FETAL MONITOR
K
97
4248
WATCHCHILD OBSTERICAL PATIENT DATA MANAGEMENT SYSTEM
K
98
0719
CALM
K
96
5008
BIRTHNET II PERINATAL PATIENT DATA MANAGEMENT SYSTEM
K
97
0456
HEWLETT APCKARD SERIES 50 OB TRACEVUE OBSTETRICAL SURVEILLANCE AND ARCHIVING SYSTEM
K
96
3711
BABY DOPPLEX (3000)
K
97
1099
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS5169
K
96
0553
CARD GUARD MODEL CG-900
K
96
3608
QUANTITATIVE SENTINEL SYSTEM
K
96
4770
COROMETRICS 120 SERIES MATERNAL/FETAL MONITOR
K
95
5931
MODEL IM77 INTRAPARTUM FETAL MONITOR (MODIFICATION)
K
96
0109
QUANTITATIVE SENTINEL SYSTEM
K
95
4351
SERIES 50XM
K
95
5559
COROMETRICS FETAL MOVEMENT DETECTION KIT
K
95
0420
FETALGARD 3000 - MODELS IP1, IP2, AP2 AND AP3
K
93
1133
CLINICAL INFOR SYST(CIS) W/FETAL MONIT REMOTE DISP
K
94
0898
MODEL IM77 INTRAPARTUM FETAL MONITOR
K
93
5377
R AND D BATTERIES
K
93
5301
R & D BATTERIES, INC. PART NUMBERS 5235, 5506 & 5050
K
94
2887
MODEL M1310A, SERIES 50T FETAL TELEMETRY SYSTEM
K
93
4959
MODEL 118 FETAL/MATERNAL MONITOR
K
93
2077
MODEL 151 FETAL MONITOR
K
92
5572
MITYVAC DISPOS-A-PLATE DISPOSABLE LEG PLATE
K
92
1956
HEWLETT PACKARD MODEL M1353A FETAL MONITOR
K
92
1957
HEWLETT-PACKARD MODEL M1351A FETAL MONITOR
K
92
0376
COROMETRICS MODEL 150 FETAL MONITOR
K
91
2138
HOMEVUE MONITORING SYS.MODEL TD 2000
K
91
2890
MODEL SONICAID AXIS
K
91
2639
SONICAID TEAM
K
91
0169
FETALGARD 2000
K
91
0418
LIFE-TRACE DISPOSABLE LEG PLATE PRODUCT # LT-100
K
91
0260
COROMETRICS MDL 330 FETAL/MATERNAL TELEMETRY SYST
K
90
5606
EXTERNAL FETAL MONITOR TRANSDUCER HOLDER
K
90
5295
CATALOG NUMBER 2609 LEG PLATE
K
90
2690
SONICAID MODEL MERIDIAN 800
K
90
3992
CYGNET CENTRAL
K
90
4358
MODEL 855 ENHANCED PERFORMANCE REMOTE TERMINAL
K
90
2802
FETAL MONITORING TRANSDUCER STRAP
K
90
0480
M1350A FETAL MONITOR (INTRAPARTUM)
K
89
3981
WATCHCHILD
K
89
5045
MODEL 410T TELECOMMUNICATION SYSTEM
K
89
4036
TOITU FETAL ACTOCARDIOGRAPH, MT-332
K
89
4958
MODEL 410 ALERT AND TELECOMMUNICATION SYSTEM
K
89
2501
WRIGHT MEDICAL FETASAFE
K
89
2354
ODIS - OBSTETRICAL DISPLAY INFO SYSTEM, HP M1370A
K
89
1595
MODEL 116 FETAL MONITOR
K
88
2084
GENESIS TM FETAL SYSTEM
K
88
2966
MODEL 320 FETAL/MATERNAL TELEMETRY SYSTEM
K
88
0419
MODEL 800 O.B. DATA ARCHIVAL SYSTEM
K
87
1082
FETAL CARE MONITOR ANTEPARTUM 1500
K
87
1383
FETALERT ADR FETAL MONITOR
K
87
1385
MODEL U-1000 WITH GESTATIONAL AGE CALCULATION
K
87
0692
PERINATAL COMPUTERS 2015/2025/2040/2045/2080/2085
K
86
0237
OMF-7101 FETAL MONITOR
K
86
1544
MODEL 80225A OBSTETRICAL MANAGEMENT SYSTEM
K
86
1556
MODIFIED FETAL MONITOR MODEL FM-2
K
86
1455
MODEL DT-102 DATA TELEPHONE TRANSMITTER
K
86
0295
FETASCAN 1500
K
86
1189
TECNOL SECURE-ALL FETAL MONITOR STRAP
K
85
5044
PERINATAL COMPUTER SYS MODEL 100A & 100B
K
85
2704
TWEETHEART #102 FETAL/NEONATAL HEARTBEAT ANNUNCIAT
K
85
2608
SPECTRA 400 EXTENDED SURVEILLANCE & ALERT SYSTEM
K
84
2422
KONTRON FAX FETAL MONITOR
K
85
2518
MODIFICATION FETAL MONITOR MODEL FM-2
K
85
2076
MODEL 145 FETAL MONITOR
K
85
1252
COROMETRICS 115 FETAL MONITOR W/DUAL CARDIOTACHOME
K
84
4724
FETAL TELEMETRY SYSTEM
K
84
3918
COROMETRICS FETAL MONITOR 142
K
84
3385
COROMETRICS 115 FETAL MONITOR
K
84
1477
COROMETRICS 815 FETAL ECG RECORDER
K
83
2849
FETAL MONITOR #FM-2
K
83
1114
EPCOM EMS-330 FREEDOM I TELEDOP OBSTET
K
83
1113
EPCOM EMS-310 INTRAPARTUM MONITOR
K
83
1115
EPCOM EMS-320 REMOTE MONITORSCOPE
K
83
1852
FETAL MONITOR #115
K
83
1371
MODEL FM5
K
82
3188
M2000 INTRAPARTUM FETAL MONITOR
K
82
3081
M2100 ANTEPARTUM FETAL MONITOR
K
82
2830
MEDICAL LABS FETAL SCAN #1000 W/CENTRAL
K
82
1478
TELEPHONE LINK DATA TRANSMISSION SYS
K
82
1580
FETAL MONITOR #FM 750
K
82
1479
CENTRAL DISPLAY SYSTEM #CS400
K
81
3457
FETASCAN 2000,2000A OBSTETRICAL DATA
K
81
3458
FETASCAN 1000, 1000A OBSTETRICAL DATA
K
81
3007
EPCOM EMS-180 ANTEPARTUM FETAL MONITOR
K
81
2863
FETASONDE 5, #30, CENTRAL NURSING STAT
K
81
2256
MODEL AP 180 MINI-MONITOR
K
80
1747
TERUMO FETAL MONITOR # FHM-602
K
80
0013
FETAL MONITOR MODEL FHM-1
K
79
1039
FETASONDE FETAL HEART RATE VARIABILITY
K
79
1037
FETASONDE LABOR STATUS DISPLAY
K
79
1036
FETASONDE UTERINE WORK MONITOR
K
79
1035
FETASONDE FETAL ACTIVITY MONITOR
K
79
1038
FETASONDE UTERINE ACTIVITY MONITOR
K
79
0761
FETASONDE MODEL 2108
K
79
0139
MONITOR, OFFICE MODEL 140
K
78
1359
MODEL 80032A, OBSTETRICAL TELEMETRY
K
78
1360
MODEL 80100A, PATIENT DATA MEMORY
K
78
0177
FETAL MONITOR MODEL 112
K
78
0176
DISPLAY SYSTEM MODEL 428
K
77
1541
FETAL MONITORING SYSTEM
K
77
1379
FETAL MONITORING SYS. MODEL FM3R
K
77
1194
FETAL/MATERNAL ALRM MODULE - 21595A
K
77
1196
MARKER GENERATOR MODULES - 21597A
K
77
1195
FETAL/MATERNAL REPEATER - 21596A
K
77
0692
MONITOR, FETAL, NO. L04-1100
K
77
0297
FETAL MONITOR, PART #100-11009
K
77
0296
FETAL MONITOR, PART #101-11009
K
76
1201
ECHO-CARDIOTRACE, AUTOMATIC
K
76
1139
T-M (TIME-MOTION) OPTION
K
76
1030
EKOSECTOR I
K
76
0919
MODEL 2106 FETA SONDE FETAL MONITOR
HGN
Stethoscope, Fetal
HGO
Monitor, Electroencephalographic, Fetal (And Accessories)
HGP
Electrode, Circular (Spiral), Scalp And Applicator
HGS
Catheter, Intrauterine And Introducer
HHJ
Locator, Intracorporeal Device, Ultrasonic, Obstetric-Gynecologic
HHX
Holograph, Fetal, Acoustical
HIQ
Electrode, Clip, Fetal Scalp (And Applicator)
KNG
Monitor, Ultrasonic, Fetal
KXN
Monitor, Cardiac, Fetal
KXO
Monitor, Pressure, Intrauterine
LQK
Home Uterine Activity Monitor
MOH
Monitor, Heart Rate, Fetal, Non-Stress Test (Home Use)
NHM
Sheet, Recording, Breast Examination
NKA
System, Documentation, Breast Lesion
OSP
Uterine Electromyographic Monitor
NPB
System, Monitoring, For Progress Of Labor
Subpart D—Cardiovascular Prosthetic Devices
Subpart D—Obstetrical and Gynecological Prosthetic Devices
Subpart D—Physical Medicine Prosthetic Devices
Subpart D—Prosthetic Devices
Subpart E—Obstetrical and Gynecological Surgical Devices
Subpart F—Obstetrical and Gynecological Therapeutic Devices
Subpart F—Therapeutic Devices
Subpart G—Assisted Reproduction Devices
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
OB
/
subpart-c—obstetrical-and-gynecological-monitoring-devices
/
HGM
/
K102140
View Source
FETAL MONITORS, MODELS F2 AND F3
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K102140
510(k) Type
Traditional
Applicant
EDAN INSTRUMENTS, INC.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
1/13/2011
Days to Decision
168 days
Submission Type
Summary