The following data is part of a premarket notification filed by Agilent Technologies with the FDA for Modification To Zymed Telemetry System, Model Easiview.
| Device ID | K001308 |
| 510k Number | K001308 |
| Device Name: | MODIFICATION TO ZYMED TELEMETRY SYSTEM, MODEL EASIVIEW |
| Classification | Oximeter |
| Applicant | AGILENT TECHNOLOGIES 1201 "B" N. RICE AVE. Oxnard, CA 93030 |
| Contact | Gretel Lumley |
| Correspondent | Gretel Lumley AGILENT TECHNOLOGIES 1201 "B" N. RICE AVE. Oxnard, CA 93030 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-25 |
| Decision Date | 2000-05-17 |