The following data is part of a premarket notification filed by Btl Industries, Inc with the FDA for Btl Elite.
| Device ID | K120093 |
| 510k Number | K120093 |
| Device Name: | BTL ELITE |
| Classification | Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat |
| Applicant | BTL INDUSTRIES, INC 16 APPLETON STREET Waltham, MA 02453 |
| Contact | Marcy Moore |
| Correspondent | Marcy Moore BTL INDUSTRIES, INC 16 APPLETON STREET Waltham, MA 02453 |
| Product Code | IMJ |
| CFR Regulation Number | 890.5290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-12 |
| Decision Date | 2012-10-05 |
| Summary: | summary |