FDA.reportPublic FDA data

Fat Loss Monitor

Primary DI
00073796306342
Brand
Fat Loss Monitor
Company
Omron Healthcare, Inc.
Model
HBF-306CAN
Catalog number
HBF-306CAN
Device description
Omron Fat Loss Monitor
Published
2016-09-16
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MNWAnalyzer, Body Composition

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNWAnalyzer, Body CompositionCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K011652000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K011652000BODY FAT ANALYZER, MODEL HBF-306Omron Healthcare, Inc.2001-11-07MNW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10073796306349PackageGS13In Commercial Distribution
20073796306346PackageGS14In Commercial Distribution
00073796306342PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1007379630634910073796306349
2007379630634620073796306346
00073796306342000737963063420737963063420073796306342

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-634-4350quality@omron.com

Regulatory Flags#

DUNS number
054318779
Device count
1
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
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00073796451226Omron Micro Air Vibrating Mesh NebulizerNE-U22VNE-U22V2017-05-17
00073796453305Omron CompAir Elite Compact Compressor NebulizerNE-C30NE-C302017-05-17
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00073796760069Upper Arm Blood Pressure MonitorHEM-7600T-CD6HEM-7600T-CD62025-07-15
10073796760066Upper Arm Blood Pressure MonitorHEM-7600T-CD6HEM-7600T-CD62025-07-15
00073796736538Blood Pressure MonitorBP7365CAN-CD6BP7365CAN-CD62025-06-27
10073796736535Blood Pressure MonitorBP7365CAN-CD6BP7365CAN-CD62025-06-27
00073796343927Omron Small D-ring CuffHEM-CS24-BHEM-CS24-B2019-04-03
00073796725310Omron 5 Series Upper Arm Blood Pressure MonitorBP7250CANBP7250CAN2019-07-08
00073796735319Omron 7 Series Upper Arm Blood Pressure MonitorBP7350CANBP7350CAN2019-07-08
00073796745318Omron 10 Series Upper Arm Blood Pressure MonitorBP7450CANBP7450CAN2019-07-08
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