Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
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- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- PDQNeurosurgical Nerve Locator2Product Code
- HRWDynamometer, Nonpowered1Product Code
- K971407JTECH COMMANDER AND ALGOMETER1Cleared 510(K)
- K970870DIGIT-GRIP WITH LCD (DGR002)1Cleared 510(K)
- K894557LIGHTSCOPE SET1Cleared 510(K)
- K861396HANDHELD DYNAMOMETER, MODEL #160 AND #1111Cleared 510(K)
- K821631PINCH GAUGE, 0-301 LBS.1Cleared 510(K)
- K812343PINCH METER1Cleared 510(K)
- K801719BK-7531 PAIN THRESHOLD/FINGER FORCE GAUG1Cleared 510(K)
- K791021MUSCLE TESTING GUN1Cleared 510(K)
- K790302PRESSURE MONITOR, MODEL 2121Cleared 510(K)
- K772415DYNAMETER 50 LB.1Cleared 510(K)
- Show All 12 Submissions
- KQWGoniometer, Nonpowered1Product Code
- KQXGoniometer, Ac-Powered1Product Code
- LBBDynamometer, Ac-Powered2Product Code
- NKIGoniometer With Electrodes2Product Code
- QWPOptical Neurosurgical Nerve Locator2Product Code
- 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
- 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
LIGHTSCOPE SET
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K894557
- 510(k) Type
- Traditional
- Applicant
- OPTIK
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 8/7/1989
- Days to Decision
- 18 days