The following data is part of a premarket notification filed by Madsen Electronics (canada) Ltd. with the FDA for Hearing Aid Test System Model Hat 1000.
Device ID | K870229 |
510k Number | K870229 |
Device Name: | HEARING AID TEST SYSTEM MODEL HAT 1000 |
Classification | Calibrator, Hearing Aid / Earphone And Analysis Systems |
Applicant | MADSEN ELECTRONICS (CANADA) LTD. 2370 SPEERS ROAD P.O. BOX 535 Oakville, Ontario, CA L6j5b4 |
Contact | Gleason |
Correspondent | Gleason MADSEN ELECTRONICS (CANADA) LTD. 2370 SPEERS ROAD P.O. BOX 535 Oakville, Ontario, CA L6j5b4 |
Product Code | ETW |
CFR Regulation Number | 874.3310 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-01-21 |
Decision Date | 1987-03-13 |