The following data is part of a premarket notification filed by Henley Healthcare, Inc. with the FDA for Enraf-nonius Sonopuls 190 System.
| Device ID | K000084 |
| 510k Number | K000084 |
| Device Name: | ENRAF-NONIUS SONOPULS 190 SYSTEM |
| Classification | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat |
| Applicant | HENLEY HEALTHCARE, INC. 120 INDUSTRIAL BLVD. Sugar Land, TX 77478 |
| Contact | Rebecca Stout |
| Correspondent | Rebecca Stout HENLEY HEALTHCARE, INC. 120 INDUSTRIAL BLVD. Sugar Land, TX 77478 |
| Product Code | IMI |
| CFR Regulation Number | 890.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-01-12 |
| Decision Date | 2000-08-04 |