The following data is part of a premarket notification filed by Chester Labs, Inc. with the FDA for Graham-field Ultrasound Scanning Gel.
| Device ID | K944597 |
| 510k Number | K944597 |
| Device Name: | GRAHAM-FIELD ULTRASOUND SCANNING GEL |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| 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 | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-19 |
| Decision Date | 1995-06-21 |