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Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
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Review Panel
Miscellaneous
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
CFR Sub-Part
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart C—Cardiovascular Monitoring Devices
CFR Sub-Part
Subpart C—General Hospital and Personal Use Monitoring Devices
CFR Sub-Part
FLK
Thermometer, Clinical Mercury
2
Product Code
CAR
Monitor, Spinal-Fluid Pressure, Electrically Powered
2
Product Code
FLL
Thermometer, Electronic, Clinical
2
Product Code
FLN
Monitor, Electric For Gravity Flow Infusion Systems
2
Product Code
FMJ
Manometer, Spinal-Fluid
2
Product Code
FQA
Scale, Surgical Sponge
1
Product Code
FQZ
Thermometer, Clinical Color Change
1
Product Code
FRC
Indicator, Biological Sterilization Process
2
Product Code
FRI
Scale, Stand-On, Patient
1
Product Code
FRW
Scale, Patient
1
Product Code
K
95
5357
OLYMPIC SMART SCALE MODEL 50/50RA
1
Cleared 510(K)
K
95
5177
OLYMPIC SMART SCALE
1
Cleared 510(K)
K
95
4846
OLYMPIC SMART SCALE
1
Cleared 510(K)
K
95
2649
WARM-SCALE
1
Cleared 510(K)
K
94
3587
ADVANCED IN-BED WEIGH SYSTEM
1
Cleared 510(K)
K
93
2572
DIGITAL BABY SCALE MODEL BLB-12
1
Cleared 510(K)
K
92
6174
MODEL 9100 H.R. INFANT SCALE
1
Cleared 510(K)
K
92
6446
EZ PUMP
1
Cleared 510(K)
K
92
6058
3M MODEL 280RT RATE TAPER INFUSION PUMP
1
Cleared 510(K)
K
92
6059
3M MODEL 200RT RATE TAPER INFUSION PUMP
1
Cleared 510(K)
K
93
0626
SANITAS PATIENT SCALE
1
Cleared 510(K)
K
92
0063
DISETRONIC DOLOMAT PUMP
1
Cleared 510(K)
K
92
4847
DETECTO MODEL 6700 SERIES
1
Cleared 510(K)
K
92
2119
MODEL 5002 LIFT WEIGH-SCALE
1
Cleared 510(K)
K
92
0812
FAIRBANKS BABY SCALE
1
Cleared 510(K)
K
92
0074
ARJO CENTURY SCALES WITH REMOTE
1
Cleared 510(K)
K
91
2662
SCALE-TRONIX PLATFORM SCALE
1
Cleared 510(K)
K
91
0582
U.S. MEDICAL PS-2000 PEDIATRIC SCALE
1
Cleared 510(K)
K
91
0583
U.S. MEDICAL PS-3000 NEONATAL SCALE
1
Cleared 510(K)
K
91
0581
U.S. MEDICAL PS-1000 PEDIATRIC SCALE
1
Cleared 510(K)
K
90
5122
SENTRY SCALE
1
Cleared 510(K)
K
90
5061
APOLLO MOBILE SCALE
1
Cleared 510(K)
K
90
4138
SMART SCALE X-RAY PLATFORM
1
Cleared 510(K)
K
90
4286
SCALE-TRONIX INCUBATOR SCALE MODEL:4050/MODIFIED
1
Cleared 510(K)
K
90
2260
SCALE-TRONIX INCUBATOR SCALE MODEL:4050
1
Cleared 510(K)
K
90
2545
VAAKA BABY SCALE
1
Cleared 510(K)
K
90
1522
OLYMPIC SMART SCALE PEDIATRICS MODEL 50
1
Cleared 510(K)
K
87
2524
SAFEWEIGH MAGIC SCALE
1
Cleared 510(K)
K
87
1771
COMFORTWEIGH
1
Cleared 510(K)
K
87
1104
OLYMPIC SMART SCALE
1
Cleared 510(K)
K
87
0888
WARM WEIGH MODEL N-10 INFANT SCALE
1
Cleared 510(K)
K
86
4327
MODEL 304-S EXTERNAL MICRO-VOLUME INFUSION PUMP
1
Cleared 510(K)
K
86
4953
WEIGHMOBILE, IN BED PATIENT WEIGHING SCALE
1
Cleared 510(K)
K
86
2477
HOYER DIGITAL ELECTRONIC SCALE
1
Cleared 510(K)
K
85
3475
GRAM-MA NEONATAL SC
1
Cleared 510(K)
K
85
2278
ACME(BRAND) LOW-PROFILE WHEELCHAIR SCALE, 17400
1
Cleared 510(K)
K
85
2035
HEALTH-O-METER PHYSICIANS, DIGITAL ELEC SCALES
1
Cleared 510(K)
K
85
1014
ACME LOW-PROFILE CHAIR SCAL 7300
1
Cleared 510(K)
K
84
1534
ACME DIGITAL INFANT SCALE-30
1
Cleared 510(K)
K
83
3754
HAMILTON PEDIATRICS SCALE
1
Cleared 510(K)
K
83
0317
INFUSION PUMP ACCESS. #60-01-5
1
Cleared 510(K)
K
83
0171
DIGITAL BEDSIDE SCALE #5000
1
Cleared 510(K)
K
82
2135
SECA DIGITAL BABY SCALE 727
1
Cleared 510(K)
K
82
2042
SECA LIGHT WEIGHT BABY SCALE 744
1
Cleared 510(K)
K
82
2043
SECA CHAIR SCALE-721
1
Cleared 510(K)
K
79
1566
MODEL AS* 6C INFUSION PUMP
1
Cleared 510(K)
K
78
1832
SCALE, ACME DIGITAL BEDSIDE
1
Cleared 510(K)
K
76
0545
WEIGHING STATION, MOBILE PATIENT
1
Cleared 510(K)
JOJ
Indicator, Physical/Chemical Sterilization Process
2
Product Code
KMI
Monitor, Bed Patient
1
Product Code
KPD
Strip, Temperature, Forehead, Liquid Crystal
2
Product Code
LHB
Timer, Apgar
1
Product Code
LRT
Indicator, Sterilization
2
Product Code
MRB
Indicator, Biological, Liquid Chemical Sterilization Process
2
Product Code
MRL
Scale, Sponge, Surgical, Electrically-Powered
1
Product Code
MTC
Indicator, Chemical, Enzymatic, Sterilization Process
2
Product Code
OCI
Indicator, Physical/Chemical, Storage Temperature
2
Product Code
OZK
Thermometer, Exhaled Breath
2
Product Code
PJO
Fall Prevention Alarm/Sensor Combination Attached Or Unattached
1
Product Code
PJP
Fall Prevention Alarm/Sensor Attached Only
1
Product Code
PWW
Fever Monitoring Kit
2
Product Code
PXH
Thermometer Kit
2
Product Code
QKM
A Chemical Vapor Sterilization Multivariable Chemical Indicator
2
Product Code
SBO
Bed-Patient Activity Monitoring System
1
Product Code
Subpart D—Pathology Instrumentation and Accessories
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—General Hospital and Personal Use Therapeutic Devices
CFR Sub-Part
Subpart F—Neurological Therapeutic Devices
CFR Sub-Part
Subpart F—Physical Medicine Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Subpart G—General Hospital and Personal Use Miscellaneous Devices
CFR Sub-Part
Subpart G—Miscellaneous Devices
CFR Sub-Part
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
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 23 May 2025 at 11:06 pm
HO
/
subpart-c—general-hospital-and-personal-use-monitoring-devices
/
FRW
/
K902260
View Source
SCALE-TRONIX INCUBATOR SCALE MODEL:4050
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K902260
510(k) Type
Traditional
Applicant
SCALE-TRONIX, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/14/1990
Days to Decision
85 days
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
Subpart B—Diagnostic Devices
Subpart C—Cardiovascular Monitoring Devices
Subpart C—General Hospital and Personal Use Monitoring Devices
FLK
Thermometer, Clinical Mercury
CAR
Monitor, Spinal-Fluid Pressure, Electrically Powered
FLL
Thermometer, Electronic, Clinical
FLN
Monitor, Electric For Gravity Flow Infusion Systems
FMJ
Manometer, Spinal-Fluid
FQA
Scale, Surgical Sponge
FQZ
Thermometer, Clinical Color Change
FRC
Indicator, Biological Sterilization Process
FRI
Scale, Stand-On, Patient
FRW
Scale, Patient
K
95
5357
OLYMPIC SMART SCALE MODEL 50/50RA
K
95
5177
OLYMPIC SMART SCALE
K
95
4846
OLYMPIC SMART SCALE
K
95
2649
WARM-SCALE
K
94
3587
ADVANCED IN-BED WEIGH SYSTEM
K
93
2572
DIGITAL BABY SCALE MODEL BLB-12
K
92
6174
MODEL 9100 H.R. INFANT SCALE
K
92
6446
EZ PUMP
K
92
6058
3M MODEL 280RT RATE TAPER INFUSION PUMP
K
92
6059
3M MODEL 200RT RATE TAPER INFUSION PUMP
K
93
0626
SANITAS PATIENT SCALE
K
92
0063
DISETRONIC DOLOMAT PUMP
K
92
4847
DETECTO MODEL 6700 SERIES
K
92
2119
MODEL 5002 LIFT WEIGH-SCALE
K
92
0812
FAIRBANKS BABY SCALE
K
92
0074
ARJO CENTURY SCALES WITH REMOTE
K
91
2662
SCALE-TRONIX PLATFORM SCALE
K
91
0582
U.S. MEDICAL PS-2000 PEDIATRIC SCALE
K
91
0583
U.S. MEDICAL PS-3000 NEONATAL SCALE
K
91
0581
U.S. MEDICAL PS-1000 PEDIATRIC SCALE
K
90
5122
SENTRY SCALE
K
90
5061
APOLLO MOBILE SCALE
K
90
4138
SMART SCALE X-RAY PLATFORM
K
90
4286
SCALE-TRONIX INCUBATOR SCALE MODEL:4050/MODIFIED
K
90
2260
SCALE-TRONIX INCUBATOR SCALE MODEL:4050
K
90
2545
VAAKA BABY SCALE
K
90
1522
OLYMPIC SMART SCALE PEDIATRICS MODEL 50
K
87
2524
SAFEWEIGH MAGIC SCALE
K
87
1771
COMFORTWEIGH
K
87
1104
OLYMPIC SMART SCALE
K
87
0888
WARM WEIGH MODEL N-10 INFANT SCALE
K
86
4327
MODEL 304-S EXTERNAL MICRO-VOLUME INFUSION PUMP
K
86
4953
WEIGHMOBILE, IN BED PATIENT WEIGHING SCALE
K
86
2477
HOYER DIGITAL ELECTRONIC SCALE
K
85
3475
GRAM-MA NEONATAL SC
K
85
2278
ACME(BRAND) LOW-PROFILE WHEELCHAIR SCALE, 17400
K
85
2035
HEALTH-O-METER PHYSICIANS, DIGITAL ELEC SCALES
K
85
1014
ACME LOW-PROFILE CHAIR SCAL 7300
K
84
1534
ACME DIGITAL INFANT SCALE-30
K
83
3754
HAMILTON PEDIATRICS SCALE
K
83
0317
INFUSION PUMP ACCESS. #60-01-5
K
83
0171
DIGITAL BEDSIDE SCALE #5000
K
82
2135
SECA DIGITAL BABY SCALE 727
K
82
2042
SECA LIGHT WEIGHT BABY SCALE 744
K
82
2043
SECA CHAIR SCALE-721
K
79
1566
MODEL AS* 6C INFUSION PUMP
K
78
1832
SCALE, ACME DIGITAL BEDSIDE
K
76
0545
WEIGHING STATION, MOBILE PATIENT
JOJ
Indicator, Physical/Chemical Sterilization Process
KMI
Monitor, Bed Patient
KPD
Strip, Temperature, Forehead, Liquid Crystal
LHB
Timer, Apgar
LRT
Indicator, Sterilization
MRB
Indicator, Biological, Liquid Chemical Sterilization Process
MRL
Scale, Sponge, Surgical, Electrically-Powered
MTC
Indicator, Chemical, Enzymatic, Sterilization Process
OCI
Indicator, Physical/Chemical, Storage Temperature
OZK
Thermometer, Exhaled Breath
PJO
Fall Prevention Alarm/Sensor Combination Attached Or Unattached
PJP
Fall Prevention Alarm/Sensor Attached Only
PWW
Fever Monitoring Kit
PXH
Thermometer Kit
QKM
A Chemical Vapor Sterilization Multivariable Chemical Indicator
SBO
Bed-Patient Activity Monitoring System
Subpart D—Pathology Instrumentation and Accessories
Subpart D—Prosthetic Devices
Subpart E—Surgical Devices
Subpart F—General Hospital and Personal Use Therapeutic Devices
Subpart F—Neurological Therapeutic Devices
Subpart F—Physical Medicine Therapeutic Devices
Subpart F—Therapeutic Devices
Subpart G—General Hospital and Personal Use Miscellaneous Devices
Subpart G—Miscellaneous Devices
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
HO
/
subpart-c—general-hospital-and-personal-use-monitoring-devices
/
FRW
/
K902260
View Source
SCALE-TRONIX INCUBATOR SCALE MODEL:4050
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K902260
510(k) Type
Traditional
Applicant
SCALE-TRONIX, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/14/1990
Days to Decision
85 days