AECD ARRHYTHMIA DETECTION SOFTWARE
FDA 510(k) clearance K982710 · decided 1998-08-10
Clearance details
- K-number
- K982710
- Device name
- AECD ARRHYTHMIA DETECTION SOFTWARE
- Applicant
- Cardiac Science, Inc.
- Decision
- Substantially Equivalent - Subject to Tracking Reg.
- Date received
- 1998-08-04
- Decision date
- 1998-08-10
- Days to decision
- 6 days
- Clearance type
- Special
- Product code
- MKJ
- Device class
- 3
- Regulation number
- 870.5310
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Automated External Defibrillator (non-wearable). Model number 9200, 9200N, 9200DN, 9200RD, recall (Z-2917-2011) | Cardiac Science Corporation | 2011-08-03 |