Defibrillator Analyzer Variable Load
FDA 510(k) K153210 · Bc Group International, Inc.
510(k) numberK153210
Submission
- Device name
- Defibrillator Analyzer Variable Load
- Applicant
- Bc Group International, Inc.
Saint Charles, MO, US - Received
- November 5, 2015
- Decision date
- December 21, 2015
- 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 |
| 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 |
| K072114 | Impulse 6000D/7000DPDRL · Traditional | Fluke Biomedical | 01/28/2008SE |
| 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 |
|---|---|---|
| K110192 | Defibrillator Analyzer - DA-2006PDRL · Traditional | 02/08/2011SE |
Questions and answers
When was Defibrillator Analyzer Variable Load cleared by the FDA?
Defibrillator Analyzer Variable Load (K153210) received a 510(k) decision of Substantially Equivalent on December 21, 2015, 46 days after the submission was received.
What is the product code of K153210?
The FDA product code is DRL – Tester, Defibrillator, a Class II (moderate risk) device regulated under 21 CFR 870.5325.