Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Obstetrical and Gynecological Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- MNWAnalyzer, Body Composition2Product Code
- K231116Multi-parameter detector2Cleared 510(K)
- K140045BODY COMPOSITION ANALYZER2Cleared 510(K)
- K141483BIOSPACE BODY COMPOSITION ANALYZER2Cleared 510(K)
- K133872ARIA WIFI SMART SCALE2Cleared 510(K)
- K140594BODY FAT ANALYZER AND SCALE2Cleared 510(K)
- K130856BIA / VITALITY ANALYZER2Cleared 510(K)
- K130777INBODY2Cleared 510(K)
- K130952PRECISION ONE LIFECARE; DETECTO; DETECTO2Cleared 510(K)
- K131394TRANSTEK GLASS BODY FAT ANALYZER2Cleared 510(K)
- K130311TRANSTEK BODY FAT ANALYZER2Cleared 510(K)
- K122388SECA MEDICAL BODY COMPOSTION ANALYZER 514, SECA MBCA 514, SECA MBCA, SECA 5142Cleared 510(K)
- K123228INBODY 770, INBODY 570, INBODY S10, INBODY H20/INBODY H20(B)2Cleared 510(K)
- K123781TRANSTEK GLASS BODY FAT ANALYZER2Cleared 510(K)
- K122976BODY FAT SCALE MODEL SF-3712Cleared 510(K)
- K121971WITHINGS, SMART BODY SCALE2Cleared 510(K)
- K120896WI-FI BODY SCALE2Cleared 510(K)
- K121527WI-FI BODY SCALE2Cleared 510(K)
- K112149WEIGHT AND BODY FAT SCALE SHINE BS01052Cleared 510(K)
- K112951BODY ANALYSIS SCALE2Cleared 510(K)
- K112932TRANSTEK2Cleared 510(K)
- K111404HUIBAO BODY FAT SCALE2Cleared 510(K)
- K110689INBODY2Cleared 510(K)
- K110928BODY ANALYSIS SCALE, MODEL BG 172Cleared 510(K)
- K102191TRANSTEK GLASS BODY ANALYZER; TRANSTEK GLASS BODY ANALYZER; TRANSTEK GLASS BODY ANALYZER;TRANSTEK GLASS BODY ANALYZER2Cleared 510(K)
- K100183MODEL MC-180MA MULTI-FREQUENCY BODY COMPOSITION ANALYZER2Cleared 510(K)
- K103026ELECTRO SENSOR -BODY COMPOSITION2Cleared 510(K)
- K082254MODIFICATION TO BODYSTAT 1500MDD BODY COMPOSITION MONITORING UNIT2Cleared 510(K)
- K082255QUADSCAN 4000 BODY BODY COMPOSITION, FLUID & ILLNESS/SEGMENTAL MONITORING UNIT2Cleared 510(K)
- K101807STAYHEALTHY BODY COMPOSITION MONITOR-BCM2Cleared 510(K)
- K092786INBODY, MODELS: 270, R20, R20B2Cleared 510(K)
- K091369ELECTROFLUIDGRAPH2Cleared 510(K)
- K092431BODY COMPOSITION ANALYZER, MODEL: IOI 3532Cleared 510(K)
- K090479TANITA BODY COMPOSITION ANALYZER, MODEL SC-3312Cleared 510(K)
- K083838SCALEMAN BODY FAT SCALES, MODEL: FS-148BW1 SERIES2Cleared 510(K)
- K082253BODYSTAT 1500 BODY COMPOSITION MONITORING UNIT2Cleared 510(K)
- K081587KRELL WEIGHT & BODY FAT MONITORING SCALE, MODEL BFA-85302Cleared 510(K)
- K073334OHMNISCAN NG2Cleared 510(K)
- K073227SLIMMANAGER BODY COMPOSITION ANALYZER, MODELS N40 AND SM-3002Cleared 510(K)
- K072325BODY COMPOSITION ANALYZER, EASYBODY 202, 203, 2052Cleared 510(K)
- K071884BODY COMPOSITION ANALYZER, MODELS: X-SCAN PLUS II, GAIA 359 PLUS, PLUSAVIS 333, XBIA 500, XBIA 9002Cleared 510(K)
- K070999BC (BODY COMPOSITION SOFTWARE)2Cleared 510(K)
- K062603BIOSPACE BODY COMPOSITION ANALYZERS, MODEL INBODY 2302Cleared 510(K)
- K062652INNERSCAN BODY COMPOSITION MONITOR, INNERSCAN SEGMENTAL BODY COMPOSITION MONITOR2Cleared 510(K)
- K062043BODY COMPOSITION MONITOR WITH SCALE, MODEL HBF-5002Cleared 510(K)
- K060538BEAVERITE BODY FAT SCALES, MODELS 8901, 8903, 8905, 8909, 8911, 8915, 9563 AND 95682Cleared 510(K)
- K053556BODY COMPOSITION ANALYZER, MODELS ZEUS 9.9 AND VENUS 5.52Cleared 510(K)
- K060642DUTECK BODY COMPOSITION ANALYZER2Cleared 510(K)
- K060552BC100 BODY COMPOSITION ANALYSIS SYSTEM2Cleared 510(K)
- K052319IMPEDIMED - BODY COMPOSITION ANALYZER, MODEL IMP SFB72Cleared 510(K)
- K051675BIODYNAMICS BIA 500 BIOMPEDANCE BODY COMPOSITION ANALYZER2Cleared 510(K)
- K052678AQ-830 SLIM BODY, BODY FAT MONITOR2Cleared 510(K)
- K052646BIOSPACE BODY COMPOSITION ANALYZERS, MODELS INBODY 520, 720 AND S202Cleared 510(K)
- K052522STAYHEALTHY BODY COMPOSITION ANALYZER, MODELS BC1 AND BC22Cleared 510(K)
- K051589SLIMMANAGER, MODEL SM-X, SM-E2Cleared 510(K)
- K050395IMPEDIMED - BODY COMPOSITION ANALYSIS2Cleared 510(K)
- K043414HL 188 & HL 189 BODY FAT METER2Cleared 510(K)
- K043060OMRON FAT LOSS MONITOR WITH SCALE, MODEL HBF-4002Cleared 510(K)
- K042528INBODY, MODEL 3.02Cleared 510(K)
- K040778TANITA INNERSCAN BODY COMPOSITION MONITOR, MODEL BC-53X (WHERE X=0 TO 9)2Cleared 510(K)
- K040978TANITA SCALE PLUS BODY FAT MONITOR WITH BODY WATER PERCENTAGE2Cleared 510(K)
- K033157TANITA SEGMENTAL BODY COMPOSITION ANALYZER, MODEL BC-4182Cleared 510(K)
- K031167HIGH PRECISION BODY WEIGHT MONITOR WITH BODY FAT INDEX2Cleared 510(K)
- K023429ROWENTA INC. BODYPARTNER VISION, MODEL BM 210 (2079565620)2Cleared 510(K)
- K031582WRIST BLOOD PRESSURE MONITOR & FAT METER, MODEL WT-202Cleared 510(K)
- K023817SMARTSHAPE BODY COMPOSITION ANALYZER, MODEL 40102Cleared 510(K)
- K020738AVITA BF1 (VITALIO) BODY FAT ANALYZER2Cleared 510(K)
- K023478INBODY AP1 BODY COMPOSITION ANALYZER2Cleared 510(K)
- K030349HEALTHOMETER PROFESSIONAL BODY FAT MONITOR AND SCALE, MODELS BFM 940, BFM 945 & BFM 9602Cleared 510(K)
- K030203LONG WELL LW-6DXX SERIES BODY FAT ANALYZER2Cleared 510(K)
- K023942CLOCKMINI, MODEL DF301; CLOCKNAVI, MODEL DF3112Cleared 510(K)
- K014009TANITA BODY COMPOSITION ANALYZER; TANITA BODY FAT MONITOR; TANITA ULTIMATE SCALE2Cleared 510(K)
- K011652BODY FAT ANALYZER, MODEL HBF-3062Cleared 510(K)
- K010706THINNER RESOLVE FITNESS MONITOR/BODY SCALE, HEALTH-O-METER2Cleared 510(K)
- K002835BODYSTAT2Cleared 510(K)
- K994242BODYSTAT 1500MDD BODY COMPOSITION MONITORING UNIT2Cleared 510(K)
- K963271FUTREX-6100/XL2Cleared 510(K)
- K980971BODYSTAT DUALSCAN 20052Cleared 510(K)
- K971554BODYSTAT2Cleared 510(K)
- K963575HBF-1000 OMRON BODY COMPOSITION ANALYZER2Cleared 510(K)
- OBHMonitor, Extracellular Fluid, Lymphedema, Extremity2Product Code
- OMVUltrasonic Body Composition Analyzer2Product Code
- PUHAnalyzer, Body Composition, Exempt2Product Code
- QJBAdjunct Monitor, Protein Calorie Malnutrition2Product Code
- Subpart C—Monitoring DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Obstetrical and Gynecological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
OMRON FAT LOSS MONITOR WITH SCALE, MODEL HBF-400
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K043060
- 510(k) Type
- Traditional
- Applicant
- Omron Healthcare, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 1/19/2005
- Days to Decision
- 75 days
- Submission Type
- Statement