The following data is part of a premarket notification filed by Fluke Biomedical with the FDA for Impulse 6000d/7000dp.
| Device ID | K072114 |
| 510k Number | K072114 |
| Device Name: | IMPULSE 6000D/7000DP |
| 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 | 2007-08-01 |
| Decision Date | 2008-01-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850540007119 | K072114 | 000 |