The following data is part of a premarket notification filed by Agilent Technologies with the FDA for Zymed Model 1610.
| Device ID | K895208 |
| 510k Number | K895208 |
| Device Name: | ZYMED MODEL 1610 |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | AGILENT TECHNOLOGIES 20 NORTH AVIADOR ST. Camarillo, CA 93010 |
| Contact | Jose R Gonzalez |
| Correspondent | Jose R Gonzalez AGILENT TECHNOLOGIES 20 NORTH AVIADOR ST. Camarillo, CA 93010 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-17 |
| Decision Date | 1989-12-12 |