Cardiac Care Q/C Test Kit
FDA 510(k) K782033 · Instrumentation Laboratory CO
510(k) numberK782033
Submission
- Device name
- Cardiac Care Q/C Test Kit
- Applicant
- Instrumentation Laboratory CO
Mchenry, IL, US - Received
- December 6, 1978
- Decision date
- December 15, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DRL – Tester, Defibrillator
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5325
- Specialty
- Cardiovascular
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|---|---|---|---|
| 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 |
| 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 |
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| K223090 | GEM Premier ChemSTATCGA · Special | 01/27/2023SE |
| K223402 | HemosIL von Willebrand Factor AntigenGGP · Special | 12/09/2022SE |
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Questions and answers
When was Cardiac Care Q/C Test Kit cleared by the FDA?
Cardiac Care Q/C Test Kit (K782033) received a 510(k) decision of Substantially Equivalent on December 15, 1978, 9 days after the submission was received.
What is the product code of K782033?
The FDA product code is DRL – Tester, Defibrillator, a Class II (moderate risk) device regulated under 21 CFR 870.5325.