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- MiscellaneousMiscellaneous
- Subpart B—Physical Medicine Diagnostic DevicesCFR Sub-Part
- IKDCable, Electrode2Product Code
- IKETransducer, Miniature Pressure1Product Code
- IKKSystem, Isokinetic Testing And Evaluation2Product Code
- IKOHammer, Reflex, Powered2Product Code
- IKPChronaximeter2Product Code
- ISBStimulator, Muscle, Diagnostic2Product Code
- JFCSystem, Pressure Measurement, Intermittent1Product Code
- K924705FORCE SENSING ARRAY1Cleared 510(K)
- K925258DYNAMIC PRESSURE MONITOR 2000M AND 2000C1Cleared 510(K)
- K925052QA PRESSURE MEASUREMENT SYSTEM1Cleared 510(K)
- K915278CDG GAIT ANALYSES SYSTEM1Cleared 510(K)
- K914776OXFORD PRESSURE MONITOR/TALLEY PRESSURE MONITOR1Cleared 510(K)
- K913510MECHANICAL SHAPE SENSOR1Cleared 510(K)
- K881284COMPUTERIZED ORTHOPAEDIC PEDOTOPOGRAPHY MACHINE1Cleared 510(K)
- K8821392P-QDA FOOT PRESSURE SYSTEMS REAL TIME1Cleared 510(K)
- K861260PEDABAROGRAPH1Cleared 510(K)
- K831800TEXAS INTERFACE PRESSURE EVALUATOR-TIPE1Cleared 510(K)
Show All 11 Submissions
- KHXPlatform, Force-Measuring1Product Code
- OALExercise Equipment, Powered, Emg-Triggered2Product Code
- Subpart D—Physical Medicine Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
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QA PRESSURE MEASUREMENT SYSTEM
- Page Type
- Cleared 510(K)
- 510(k) Number
- K925052
- 510(k) Type
- Traditional
- Applicant
- GABEL MEDICAL INSTRUMENTS, LTD.
- Country
- Canada
- FDA Decision
- Substantially Equivalent
- Decision Date
- 3/9/1993
- Days to Decision
- 154 days
- Submission Type
- Statement