The following data is part of a premarket notification filed by Agilent Technologies with the FDA for 2010 Plus Holter For Windows.
| Device ID | K003940 |
| 510k Number | K003940 |
| Device Name: | 2010 PLUS HOLTER FOR WINDOWS |
| Classification | Electrocardiograph, Ambulatory, With Analysis Algorithm |
| 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 | MLO |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-21 |
| Decision Date | 2001-02-08 |
| Summary: | summary |