Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- 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
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- 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
- KCYTourniquet, Pneumatic1Product Code
- KPJChamber, Oxygen, Topical, Extremity2Product Code
- K190742EPIFLO-282Cleared 510(K)
- K112634NATROX TOPICAL OXYGEN DELIVERY SYSTEM WITH IODP2Cleared 510(K)
- K120764EPIFLO(R)2Cleared 510(K)
- K090681TANSCU O22Cleared 510(K)
- K080966HYPER-BOX TOPICAL WOUND OXYGEN SYSTEM2Cleared 510(K)
- K050156WHS-1000 WOUND HEALING SYSTEM2Cleared 510(K)
- K023456OXYBOX SYSTEM2Cleared 510(K)
- K022028VX-400 TOPICAL HYPERBARIC OXYGEN CHAMBER2Cleared 510(K)
- K020466HEC 10002Cleared 510(K)
- K002632OXYGENATOR2Cleared 510(K)
- K981949NUMOBAG2Cleared 510(K)
- K971507O2 BOOT2Cleared 510(K)
- K960756LIFETECH CASSETTE2Cleared 510(K)
- K963777HYPER PULSE INTERMITTENT TOPICAL OXYGEN CHAMBER C-100, CB-1002Cleared 510(K)
- K920948TOPICAL SACRAL HYPERBARIC OXYGEN CHAMBER2Cleared 510(K)
- K883848KMI OXY-BAN2Cleared 510(K)
- K882461O2 CARE2Cleared 510(K)
- K861593TOPICAL HYPERBARIC OXYGEN CHAMBER2Cleared 510(K)
- K861101THE NEW FLEXIBLE COLLAPSIBLE CHAMBER2Cleared 510(K)
- K840817DISPOSABLE, HYPERBARIC OXYGEN CHAMBER2Cleared 510(K)
- K831825DISPOS. HYPERBARIC OXYGEN CUSH/TRAUM2Cleared 510(K)
- 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
O2 BOOT
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K971507
- 510(k) Type
- Traditional
- Applicant
- GWR MEDICAL, LLP
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 11/7/1997
- Days to Decision
- 196 days
- Submission Type
- Summary