Medical Device Manufacturer · CA , Oakville, Ontario

Madsen Electronics (Canada) , Ltd. - FDA 510(k) Cleared Devices

17 submissions · 17 cleared · Since 1985

Recent clearances: HI-PRO/NOAH UNIVERSAL HEARING INSTRUMENT, OTOACOUSTIC EMISSIONS UNIT CELESTA 503, ORBITER 922 CLINICAL AUDIOMETER

17

Total

17

Cleared

0

Denied

FDA 510(k) Regulatory Record - Madsen Electronics (Canada) , Ltd. Neurology ✕

3 devices

1-3 of 3

Cleared Sep 30, 1986

SINGLE CHANNEL BRAIN STEM RESPONSE AUDIOMETER BSR2

Neurology · 321d

Cleared May 22, 1985

Neurology · 177d

Cleared Feb 25, 1985

VPS 2250, CSU2250 & VFU 2250

Neurology · 91d