The following data is part of a premarket notification filed by Robert Bosch Corp. with the FDA for Sonomed 4.
| Device ID | K851937 |
| 510k Number | K851937 |
| Device Name: | SONOMED 4 |
| Classification | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat |
| Applicant | ROBERT BOSCH CORP. FLOWER FIELD BLDG. #17 MILL POND ROAD St. James, NY 11780 |
| Contact | Andrew Scheeffer |
| Correspondent | Andrew Scheeffer ROBERT BOSCH CORP. FLOWER FIELD BLDG. #17 MILL POND ROAD St. James, NY 11780 |
| Product Code | IMI |
| CFR Regulation Number | 890.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-15 |
| Decision Date | 1985-07-17 |