The following data is part of a premarket notification filed by Chester Labs, Inc. with the FDA for Graham-field Ultrasound Lotion.
| Device ID | K944596 |
| 510k Number | K944596 |
| Device Name: | GRAHAM-FIELD ULTRASOUND LOTION |
| Classification | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat |
| Applicant | CHESTER LABS, INC. 3208 DIXIE HWY Erlanger, KY 41018 |
| Contact | Vera Pracht |
| Correspondent | Vera Pracht CHESTER LABS, INC. 3208 DIXIE HWY Erlanger, KY 41018 |
| Product Code | IMI |
| CFR Regulation Number | 890.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-19 |
| Decision Date | 1995-06-07 |