ACCESSAED, SEMI-AUTOMATIC EXTERNAL DEFIBRILLATORS
FDA 510(k) clearance K020984 · decided 2002-08-14
Clearance details
- K-number
- K020984
- Device name
- ACCESSAED, SEMI-AUTOMATIC EXTERNAL DEFIBRILLATORS
- Applicant
- Access Cardiosystems, Inc.
- Decision
- Substantially Equivalent - Subject to Tracking Reg.
- Date received
- 2002-03-18
- Decision date
- 2002-08-14
- Days to decision
- 149 days
- Clearance type
- Traditional
- Product code
- MKJ
- Device class
- 3
- Regulation number
- 870.5310
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Concord, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| AccessAED (without audio record) Model Number: 9100-0100-0 recall (Z-0199-05) | Access CardioSystems | 2004-11-20 |
| Access AED and Access ALS Automated External Defibrillators Model No. : 9100-0100 recall (Z-0356-04) | Access CardioSystems | 2004-07-20 |