Anesthesiology
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- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Physical Medicine Diagnostic DevicesCFR Sub-Part
- KZMDevice, Muscle Monitoring2Product Code
- K161716TEETHAN 2.02Cleared 510(K)
- K130158M-SCAN2Cleared 510(K)
- K113677GRINDCARE MEASURE2Cleared 510(K)
- K082927BIOEMG III2Cleared 510(K)
- K043373DOLOTENS DENTAL TM 12Cleared 510(K)
- K030869BITESTRIP2Cleared 510(K)
- K003176BIOEMG II AND BIOJVA2Cleared 510(K)
- K003287MODEL K7 EVALUATION DEVICE2Cleared 510(K)
- K992694MODIFICATION TO K6-I DIAGNOSTIC SYSTEM, MODEL K6-I2Cleared 510(K)
- K981563BIOPAK MEASUREMENT SYSTEM2Cleared 510(K)
Show All 19 Submissions
- Subpart D—Physical Medicine Prosthetic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- Subpart G—Miscellaneous DevicesCFR Sub-Part
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M-SCAN
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K130158
- 510(k) Type
- Traditional
- Applicant
- Bio-Research Associates, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 7/25/2013
- Days to Decision
- 183 days
- Submission Type
- Summary