The following data is part of a premarket notification filed by C.l. Mcintosh & Assoc., Inc. with the FDA for Orthosonics Duo-son Ultrasound Diathermy Device.
| Device ID | K970131 |
| 510k Number | K970131 |
| Device Name: | ORTHOSONICS DUO-SON ULTRASOUND DIATHERMY DEVICE |
| Classification | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat |
| Applicant | C.L. MCINTOSH & ASSOC., INC. 12300 TWINBROOK PKWY. SUITE 625 Rockville, MD 20852 |
| Contact | T. Whit Athey, Ph.d. |
| Correspondent | T. Whit Athey, Ph.d. C.L. MCINTOSH & ASSOC., INC. 12300 TWINBROOK PKWY. SUITE 625 Rockville, MD 20852 |
| Product Code | IMI |
| CFR Regulation Number | 890.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-14 |
| Decision Date | 1997-06-16 |
| Summary: | summary |