The following data is part of a premarket notification filed by Agilent Technologies, Inc. with the FDA for Pagewriter 10/10i, Model M2662a Handheld Electrocardiograph.
| Device ID | K002459 |
| 510k Number | K002459 |
| Device Name: | PAGEWRITER 10/10I, MODEL M2662A HANDHELD ELECTROCARDIOGRAPH |
| Classification | Electrocardiograph |
| Applicant | AGILENT TECHNOLOGIES, INC. 3000 MINUTEMAN RD. Andover, MA 01810 -1099 |
| Contact | Rob Butler |
| Correspondent | Rob Butler AGILENT TECHNOLOGIES, INC. 3000 MINUTEMAN RD. Andover, MA 01810 -1099 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-10 |
| Decision Date | 2000-11-08 |