The following data is part of a premarket notification filed by Bowen & Company, Inc. with the FDA for Bowen Reuseable/disposable Electrode.
| Device ID | K871325 |
| 510k Number | K871325 |
| Device Name: | BOWEN REUSEABLE/DISPOSABLE ELECTRODE |
| Classification | Electrode, Electrocardiograph |
| Applicant | BOWEN & COMPANY, INC. 1800 CHAPMAN AVE. Rockville, MD 20852 |
| Contact | Susan L Brandt |
| Correspondent | Susan L Brandt BOWEN & COMPANY, INC. 1800 CHAPMAN AVE. Rockville, MD 20852 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-04-03 |
| Decision Date | 1987-06-08 |