Anesthesiology
Review Panel
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- ChemistryReview Panel
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- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Neurological Diagnostic DevicesCFR Sub-Part
- Subpart B—Physical Medicine Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart D—Physical Medicine Prosthetic DevicesCFR Sub-Part
- PHLPowered Exoskeleton2Product Code
- K233695Medical HAL Lower Limb Type (HAL-ML)2Cleared 510(K)
- K232077Atalante X2Cleared 510(K)
- K221696ReWalk P6.02Cleared 510(K)
- K221859Atalante2Cleared 510(K)
- K220988EksoNR2Cleared 510(K)
- K213452GEMS-H2Cleared 510(K)
- K201473ExoAtlet-II2Cleared 510(K)
- K201559HAL for Medical Use(Lower Limb type)2Cleared 510(K)
- K201539Keeogo Dermoskeleton System2Cleared 510(K)
- K200574EksoNR2Cleared 510(K)
Show All 22 Submissions
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Cardiovascular Therapeutic DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- 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
GEMS-H
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K213452
- 510(k) Type
- Traditional
- Applicant
- Samsung Electronics Co., Ltd.
- Country
- South Korea
- FDA Decision
- Substantially Equivalent
- Decision Date
- 4/21/2022
- Days to Decision
- 177 days
- Submission Type
- Summary