The following data is part of a premarket notification filed by Agilent Technologies, Inc. with the FDA for Heartstream Xl Defibrillator/monitor, Model M4735a.
| Device ID | K001725 |
| 510k Number | K001725 |
| Device Name: | HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL M4735A |
| Classification | Automated External Defibrillators (non-wearable) |
| Applicant | AGILENT TECHNOLOGIES, INC. 3000 MINUTEMAN RD. Andover, MA 01810 -1099 |
| Contact | Richard J Petersen |
| Correspondent | Richard J Petersen AGILENT TECHNOLOGIES, INC. 3000 MINUTEMAN RD. Andover, MA 01810 -1099 |
| Product Code | MKJ |
| Subsequent Product Code | DQA |
| Subsequent Product Code | DRO |
| Subsequent Product Code | LDD |
| CFR Regulation Number | 870.5310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-06 |
| Decision Date | 2000-09-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838011939 | K001725 | 000 |
| 00884838011922 | K001725 | 000 |