Anesthesiology
Review Panel
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- ChemistryReview Panel
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- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
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- Diagnostic DevicesCFR Sub-Part
- General Hospital and Personal Use Monitoring DevicesCFR Sub-Part
- General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- MiscellaneousMiscellaneous
- Neurological Surgical DevicesCFR Sub-Part
- Physical Medicine Therapeutic DevicesCFR Sub-Part
- Prosthetic DevicesCFR Sub-Part
- Surgical DevicesCFR Sub-Part
- Therapeutic DevicesCFR Sub-Part
- NGUBalloon, Liver Tamponade2Product Code
- EYRTourniquet, Gastro-Urology1Product Code
- EXMTruss, Umbilical1Product Code
- EYNTray, Irrigation, Sterile2Product Code
- FBQTrocar, Gastro-Urology2Product Code
- FZGApparatus, Air Handling, Bench2Product Code
- FZHApparatus, Air Handling, Room2Product Code
- FZIApparatus, Air Handling, Enclosure2Product Code
- GAXTourniquet, Nonpneumatic1Product Code
- KCWEpilator, High Frequency, Needle-Type1Product Code
- KCXEpilator, High Frequency, Tweezer-Type1Product Code
- K973773DAPELLE HAIR REMOVER1Cleared 510(K)
- K973340TWEEZER-TYPE EPILATOR1Cleared 510(K)
- K973179FEMINIQUE SONIC HAIR REMOVER1Cleared 510(K)
- K973174SONIQUE HAIR REMOVER1Cleared 510(K)
- K972695FINALLY FREE1Cleared 510(K)
- K970338TWEEZER-TYPE EPILATOR1Cleared 510(K)
- K935706EPI 21Cleared 510(K)
- K943872COMMANDER MARK II HAIR REMOVAL SYSTEM1Cleared 510(K)
- K952117EPILATOR1Cleared 510(K)
- K915845HAIR TRONICS MODEL HT80001Cleared 510(K)
- Show All 25 Submissions
- KCYTourniquet, Pneumatic1Product Code
- KPJChamber, Oxygen, Topical, Extremity2Product Code
- OJSTourniquet Kit1Product Code
- OLIFat Reducing Low Level Laser2Product Code
- PKTLaser For Disruption Of Adipocyte Cells For Aesthetic Use2Product Code
- QGXGeneral Use Pneumatic Tourniquet1Product Code
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
EPI 2
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K935706
- 510(k) Type
- Traditional
- Applicant
- UNIVERSAL H.R. SYSTEM, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 2/11/1997
- Days to Decision
- 1169 days
- Submission Type
- Statement