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 |