The following data is part of a premarket notification filed by Bio-tek Instruments, Inc. with the FDA for The Bio-tek Uw-ii.
| Device ID | K862932 |
| 510k Number | K862932 |
| Device Name: | THE BIO-TEK UW-II |
| Classification | Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat |
| Applicant | BIO-TEK INSTRUMENTS, INC. HIHGLAND PARK BOX 998 Winooski, VT 05404 |
| Contact | Dave Klyszeiko |
| Correspondent | Dave Klyszeiko BIO-TEK INSTRUMENTS, INC. HIHGLAND PARK BOX 998 Winooski, VT 05404 |
| Product Code | IMJ |
| CFR Regulation Number | 890.5290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-08-04 |
| Decision Date | 1986-09-25 |