The following data is part of a premarket notification filed by Chester Labs, Inc. with the FDA for Graham-field Conductive Ecg Spray.
| Device ID | K944599 |
| 510k Number | K944599 |
| Device Name: | GRAHAM-FIELD CONDUCTIVE ECG SPRAY |
| Classification | Media, Electroconductive |
| Applicant | CHESTER LABS, INC. 1900 SECTION RD., SUITE A Cincinnati, OH 45237 |
| Contact | Holly Sherwood |
| Correspondent | Holly Sherwood CHESTER LABS, INC. 1900 SECTION RD., SUITE A Cincinnati, OH 45237 |
| Product Code | GYB |
| CFR Regulation Number | 882.1275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-19 |
| Decision Date | 1996-05-07 |