The following data is part of a premarket notification filed by Arbo Medical, Inc. with the FDA for Arbo Monitring Safety Cable & Lead Wire Systems/arbo Unsheilded Safety Cable & Lead System.
| Device ID | K940302 |
| 510k Number | K940302 |
| Device Name: | ARBO MONITRING SAFETY CABLE & LEAD WIRE SYSTEMS/ARBO UNSHEILDED SAFETY CABLE & LEAD SYSTEM |
| Classification | Cable, Transducer And Electrode, Patient, (including Connector) |
| Applicant | ARBO MEDICAL, INC. 1129 BLOOMFIELD AVE. West Caldwell, NJ 07006 |
| Contact | Wayne D Shockloss |
| Correspondent | Wayne D Shockloss ARBO MEDICAL, INC. 1129 BLOOMFIELD AVE. West Caldwell, NJ 07006 |
| Product Code | DSA |
| CFR Regulation Number | 870.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-24 |
| Decision Date | 1994-11-30 |