Anesthesiology
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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
- KQWGoniometer, Nonpowered1Product Code
- KQXGoniometer, Ac-Powered1Product Code
- LBBDynamometer, Ac-Powered2Product Code
- K162412Hoggan Scientific® microFET2™2Cleared 510(K)
- K073154FACTS HAND AND PINCH GRIP COMBO2Cleared 510(K)
- K052309DIGITAL HAND DYNAMOMETER, MODEL SH5003; DIGITAL PINCH GAUGE, MODEL SH50062Cleared 510(K)
- K042889DYNAMOMETER - MODEL FCE AND MODEL MSC2Cleared 510(K)
- K012492KADANCE 20002Cleared 510(K)
- K981730DIGIT-GRIP WITH LCD, MODEL NUMBER DGR 0022Cleared 510(K)
- K980363ORO-FACIAL MYOGRAPHIC MEASUREMENT INSTRUMENT (OMMI)2Cleared 510(K)
- K964933MEKANIKA'S SPINAL STIFFNESS GAUGE (SSG)2Cleared 510(K)
- K964685DYNAMOMETER2Cleared 510(K)
- K935757GREENLEAF EVAL SYSTEM/ GREENLEAF SOLOSYSTEM2Cleared 510(K)
- Show All 36 Submissions
- 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
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DIGITAL HAND DYNAMOMETER, MODEL SH5003; DIGITAL PINCH GAUGE, MODEL SH5006
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K052309
- 510(k) Type
- Traditional
- Applicant
- SAEHAN CORP.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 9/27/2005
- Days to Decision
- 34 days
- Submission Type
- Summary