Anesthesiology
Review Panel
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- 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)
Show All 79 Submissions
- 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
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- 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
PRECISION ONE LIFECARE; DETECTO; DETECTO
- Page Type
- Cleared 510(K)
- 510(k) Number
- K130952
- 510(k) Type
- Traditional
- Applicant
- Precision One Lifecare, Ltd.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 9/26/2013
- Days to Decision
- 174 days
- Submission Type
- Summary