Impulse 6000D/7000DP
FDA 510(k) K072114 · Fluke Biomedical
510(k) numberK072114
Submission
- Device name
- Impulse 6000D/7000DP
- Applicant
- Fluke Biomedical
Orange, CA, US - Received
- August 1, 2007
- Decision date
- January 28, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DRL – Tester, Defibrillator
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5325
- Specialty
- Cardiovascular
Other 510(k)s with product code DRL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K190437 | Delta 3300DRL · Traditional | Netech Corporation | 08/28/2019SE |
| K182905 | UniPulseDRL · Traditional | Seaward Group | 12/14/2018SE |
| K153210 | Defibrillator Analyzer Variable LoadDRL · Traditional | Bc Group International, Inc. | 12/21/2015SE |
| K110192 | Defibrillator Analyzer - DA-2006PDRL · Traditional | Bc Group International, Inc. | 02/08/2011SE |
| K083347 | Impulse 7010 Defibrillator Selectable LoadsDRL · Traditional | Fluke Biomedical | 12/24/2008SE |
| K062099 | Phase 3, Model DT-1DRL · Traditional | Datrend Systems, Inc. | 01/25/2007SE |
| K030547 | Modification to Zap Guard Defibrillator Test ProbeDRL · Special | Guardian Angel Products, Inc. | 07/11/2003SE |
| K963190 | QA-40M Defibrillator TesterDRL · Traditional | Metron U.S., Inc. | 07/01/1997SE |
| K961595 | Defibrillator Analyzer, Delta 1000DRL · Traditional | Netech Corp. | 10/29/1996SE |
| K954391 | Models QED-6, 6M and 6H Defibrillator Analyzer with Optional Universal Pacemaker Load…DRL · Traditional | Bio-Tek Instruments, Inc. | 11/17/1995SE |
More from Bio-Tek Instruments, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K121860 | ESA615DRT · Traditional | 01/25/2013SE |
| K121722 | ESA620 Electrical Safety AnalyzerDRT · Traditional | 10/11/2012SE |
| K110429 | Prosim 4, Prosim 6, Prosim 8DRT · Traditional | 09/02/2011SE |
| K103336 | MPS450 Multiparameter SimulatorDRT · Traditional | 04/13/2011SE |
| K083347 | Impulse 7010 Defibrillator Selectable LoadsDRL · Traditional | 12/24/2008SE |
Questions and answers
When was Impulse 6000D/7000DP cleared by the FDA?
Impulse 6000D/7000DP (K072114) received a 510(k) decision of Substantially Equivalent on January 28, 2008, 180 days after the submission was received.
What is the product code of K072114?
The FDA product code is DRL – Tester, Defibrillator, a Class II (moderate risk) device regulated under 21 CFR 870.5325.