FDA 510(k), K970685, EARCHECK PRO
FDA 510(k), K970685, EARCHECK PRO
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$149.00 USD
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510(K) Number: K970685
Device Name: EARCHECK PRO
Manufacturer: MDI INSTRUMENTS, INC.
Device Classification Name: tester, auditory impedance
Regulation Number: 874.1090
Classification Product Code: ETY
Date Received: 02/24/1997
Decision Date: 05/28/1997
Regulation Medical Specialty: Ear Nose & Throat
Device Name: EARCHECK PRO
Manufacturer: MDI INSTRUMENTS, INC.
Device Classification Name: tester, auditory impedance
Regulation Number: 874.1090
Classification Product Code: ETY
Date Received: 02/24/1997
Decision Date: 05/28/1997
Regulation Medical Specialty: Ear Nose & Throat