The following data is part of a premarket notification filed by Arbo Medical, Inc. with the FDA for Arbo H90, H91, H135 Disposable Monitoring Electrodes.
| Device ID | K935429 |
| 510k Number | K935429 |
| Device Name: | ARBO H90, H91, H135 DISPOSABLE MONITORING ELECTRODES |
| Classification | Electrode, Electrocardiograph |
| Applicant | ARBO MEDICAL, INC. 300 LONG BEACH BLVD. Stratford, CT 06497 |
| Contact | Jeffrey M Block |
| Correspondent | Jeffrey M Block ARBO MEDICAL, INC. 300 LONG BEACH BLVD. Stratford, CT 06497 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-10 |
| Decision Date | 1994-11-01 |