IMPULSE 3000 DEFIBRILLATOR ANALYZER
FDA 510(k) clearance K934254 · decided 1993-11-23
Clearance details
- K-number
- K934254
- Device name
- IMPULSE 3000 DEFIBRILLATOR ANALYZER
- Applicant
- Dynatech/Nevada, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-08-31
- Decision date
- 1993-11-23
- Days to decision
- 84 days
- Clearance type
- Traditional
- Product code
- DRL
- Device class
- 2
- Regulation number
- 870.5325
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Delta 3300 (K190437) | Netech Corporation | 2019-08-28 |
| UniPulse (K182905) | Seaward Group | 2018-12-14 |
| Defibrillator Analyzer Variable Load (K153210) | Bc Group International, Inc. | 2015-12-21 |
| DEFIBRILLATOR ANALYZER - DA-2006P (K110192) | Bc Group International, Inc. | 2011-02-08 |
| IMPULSE 7010 DEFIBRILLATOR SELECTABLE LOADS (K083347) | Fluke Biomedical | 2008-12-24 |
| IMPULSE 6000D/7000DP (K072114) | Fluke Biomedical | 2008-01-28 |
| PHASE 3, MODEL DT-1 (K062099) | Datrend Systems, Inc. | 2007-01-25 |
| MODIFICATION TO ZAP GUARD DEFIBRILLATOR TEST PROBE (K030547) | Guardian Angel Products, Inc. | 2003-07-11 |
| QA-40M DEFIBRILLATOR TESTER (K963190) | Metron U.S., Inc. | 1997-07-01 |
| DEFIBRILLATOR ANALYZER, DELTA 1000 (K961595) | Netech Corp. | 1996-10-29 |
| MODELS QED-6, 6M AND 6H DEFIBRILLATOR ANALYZER WITH OPTIONAL UNIVERSAL PACEMAKER LOAD ADAPTER (K954391) | Bio-Tek Instruments, Inc. | 1995-11-17 |
| IMPULSE 4000 DEFIBRILLATOR/TRANSCUTANEOUS PACER ANALYZER (K941404) | Hogan & Hartson | 1994-06-29 |
Recalls involving this device
No recalls on record reference this clearance.