The following data is part of a premarket notification filed by Fluke Biomedical with the FDA for Impulse 7010 Defibrillator Selectable Loads.
| Device ID | K083347 |
| 510k Number | K083347 |
| Device Name: | IMPULSE 7010 DEFIBRILLATOR SELECTABLE LOADS |
| Classification | Tester, Defibrillator |
| Applicant | FLUKE BIOMEDICAL 1717 WEST COLLINS AVE. Orange, CA 92867 |
| Contact | Colleen Boswell |
| Correspondent | Colleen Boswell FLUKE BIOMEDICAL 1717 WEST COLLINS AVE. Orange, CA 92867 |
| Product Code | DRL |
| CFR Regulation Number | 870.5325 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-13 |
| Decision Date | 2008-12-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850540007140 | K083347 | 000 |