510(k) K963190
- Device
- QA-40M DEFIBRILLATOR TESTER
- Applicant
- METRON U.S., INC.
- 510(k) number
- K963190
- Product code
- DRL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-07-01
- Date received
- 1996-08-15
- Regulation
- 870.5325
- Classification name
- Tester, Defibrillator
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- JIM QUINN
- Address
- 1345 Monroe, NW, #255a Grand Rapids MI US 49505 49505
FDA Registration Numbers#
- 9615335
- 2939012
- 2921581
- 2436826
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DRL #
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|---|---|---|---|
| K190437 | Delta 3300 | Netech Corporation | 2019-08-28 |
| K182905 | UniPulse | Seaward Group | 2018-12-14 |
| K153210 | Defibrillator Analyzer Variable Load | Bc Group International, Inc. | 2015-12-21 |
| K110192 | DEFIBRILLATOR ANALYZER - DA-2006P | Bc Group International, Inc. | 2011-02-08 |
| K083347 | IMPULSE 7010 DEFIBRILLATOR SELECTABLE LOADS | Fluke Biomedical | 2008-12-24 |
| K072114 | IMPULSE 6000D/7000DP | Fluke Biomedical | 2008-01-28 |
| K062099 | PHASE 3, MODEL DT-1 | Datrend Systems, Inc. | 2007-01-25 |
| K030547 | MODIFICATION TO ZAP GUARD DEFIBRILLATOR TEST PROBE | Guardian Angel Products, Inc. | 2003-07-11 |
| K961595 | DEFIBRILLATOR ANALYZER, DELTA 1000 | Netech Corp. | 1996-10-29 |
| K954391 | MODELS QED-6, 6M AND 6H DEFIBRILLATOR ANALYZER WITH OPTIONAL UNIVERSAL PACEMAKER LOAD ADAPTER | Bio-Tek Instruments, Inc. | 1995-11-17 |
| K941404 | IMPULSE 4000 DEFIBRILLATOR/TRANSCUTANEOUS PACER ANALYZER | Hogan & Hartson | 1994-06-29 |
| K934254 | IMPULSE 3000 DEFIBRILLATOR ANALYZER | Dynatech/Nevada, Inc. | 1993-11-23 |
| K904159 | DEFIBRILLATOR ANALYZER MODEL QED-5 | Bio-Tek Instruments, Inc. | 1991-03-18 |
| K896985 | ZAP-GUARD | Guardian Angel Products, Inc. | 1990-07-31 |
| K895525 | MATRX BATTERY CHARGER/DEFIBRILLATOR TESTER | Matrix Medica, Inc. | 1990-01-26 |
Legacy Summary#
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FDA Review#
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