Anesthesiology
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- MiscellaneousMiscellaneous
- Subpart B—Physical Medicine Diagnostic DevicesCFR Sub-Part
- IKDCable, Electrode2Product Code
- IKETransducer, Miniature Pressure1Product Code
- K060125SONIC PALPOMETER1Cleared 510(K)
- K954670PRESSORE MONITOR1Cleared 510(K)
- K915369THE EQUALIZER1Cleared 510(K)
- K915326PORTABLE LIMB LOAD MONITOR (BMLLM-100)1Cleared 510(K)
- K920091IOWA ORAL PERFORMANCE ISNTRUMENT1Cleared 510(K)
- K915897FPL1Cleared 510(K)
- K914780TALLEY SD.500 SKIN PRESSURE EVALUATOR1Cleared 510(K)
- K902967MICRO-EMED-SYSTEM1Cleared 510(K)
- K880912DYNATRON 20001Cleared 510(K)
- K875103BIO-FEEDBACK LIMB MONITOR TYPE CODE BL-34-11Cleared 510(K)
Show All 15 Submissions
- IKKSystem, Isokinetic Testing And Evaluation2Product Code
- IKOHammer, Reflex, Powered2Product Code
- IKPChronaximeter2Product Code
- ISBStimulator, Muscle, Diagnostic2Product Code
- JFCSystem, Pressure Measurement, Intermittent1Product Code
- 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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- UnknownReview Panel
IOWA ORAL PERFORMANCE ISNTRUMENT
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K920091
- 510(k) Type
- Traditional
- Applicant
- BREAK THROUGH, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 5/20/1992
- Days to Decision
- 133 days
- Submission Type
- Statement