The following data is part of a premarket notification filed by Agilent Technologies, Inc. with the FDA for Heartstream Fr2 Aed, Model M3860a,m3861a.
| Device ID | K003565 |
| 510k Number | K003565 |
| Device Name: | HEARTSTREAM FR2 AED, MODEL M3860A,M3861A |
| Classification | Automated External Defibrillators (non-wearable) |
| Applicant | AGILENT TECHNOLOGIES, INC. 2401 FOURTH AVE., SUITE 500 Seattle, WA 98121 |
| Contact | Gretchen Solberg |
| Correspondent | Gretchen Solberg AGILENT TECHNOLOGIES, INC. 2401 FOURTH AVE., SUITE 500 Seattle, WA 98121 |
| Product Code | MKJ |
| CFR Regulation Number | 870.5310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-20 |
| Decision Date | 2000-12-20 |