The following data is part of a premarket notification filed by Laborie Medical Technologies, Ltd. with the FDA for Elite Biofeedback.
Device ID | K942563 |
510k Number | K942563 |
Device Name: | ELITE BIOFEEDBACK |
Classification | Perineometer |
Applicant | LABORIE MEDICAL TECHNOLOGIES, LTD. 7 GREEN TREE DR. South Burlington, VT 05403 |
Contact | Fred Buffa |
Correspondent | Fred Buffa LABORIE MEDICAL TECHNOLOGIES, LTD. 7 GREEN TREE DR. South Burlington, VT 05403 |
Product Code | HIR |
CFR Regulation Number | 884.1425 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-05-31 |
Decision Date | 1995-06-06 |