The following data is part of a premarket notification filed by Agilent Technologies, Inc. with the FDA for Agilent M2636b Telemon B Monitor (telemon B).
| Device ID | K011824 |
| 510k Number | K011824 |
| Device Name: | AGILENT M2636B TELEMON B MONITOR (TELEMON B) |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | AGILENT TECHNOLOGIES, INC. 3000 MINUTEMAN RD. Andover, MA 01810 -1099 |
| Contact | Denise Haley |
| Correspondent | Denise Haley AGILENT TECHNOLOGIES, INC. 3000 MINUTEMAN RD. Andover, MA 01810 -1099 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-11 |
| Decision Date | 2001-07-02 |
| Summary: | summary |