The following data is part of a premarket notification filed by Arbo Medical, Inc. with the FDA for Arbo H79p Disposable Monitoring Electrodes.
| Device ID | K894562 |
| 510k Number | K894562 |
| Device Name: | ARBO H79P DISPOSABLE MONITORING ELECTRODES |
| Classification | Electrode, Electrocardiograph |
| Applicant | ARBO MEDICAL, INC. 35 DANBURY ROAD, SUITE 2 Wilton, CT 06897 |
| Contact | Wayne Shockloss |
| Correspondent | Wayne Shockloss ARBO MEDICAL, INC. 35 DANBURY ROAD, SUITE 2 Wilton, CT 06897 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-21 |
| Decision Date | 1989-09-05 |