The following data is part of a premarket notification filed by Agilent Technologies, Inc. with the FDA for Heartstream Attenuated Defibrillation Pads, Model M3870a.
| Device ID | K003819 |
| 510k Number | K003819 |
| Device Name: | HEARTSTREAM ATTENUATED DEFIBRILLATION PADS, MODEL M3870A |
| Classification | Automated External Defibrillators (non-wearable) |
| Applicant | AGILENT TECHNOLOGIES, INC. 2401 FOURTH AVE., SUITE 500 Seattle, WA 98121 |
| Contact | Teresa Skarr |
| Correspondent | Teresa Skarr AGILENT TECHNOLOGIES, INC. 2401 FOURTH AVE., SUITE 500 Seattle, WA 98121 |
| Product Code | MKJ |
| CFR Regulation Number | 870.5310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-11 |
| Decision Date | 2001-05-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838023734 | K003819 | 000 |