The following data is part of a premarket notification filed by Robert Bosch Corp. with the FDA for Ultramed 11s601.
| Device ID | K842801 |
| 510k Number | K842801 |
| Device Name: | ULTRAMED 11S601 |
| Classification | Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat |
| Applicant | ROBERT BOSCH CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IMJ |
| CFR Regulation Number | 890.5290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-07-17 |
| Decision Date | 1984-08-01 |