ABR-2000
FDA 510(k) clearance K020360 · decided 2002-08-29
Clearance details
- K-number
- K020360
- Device name
- ABR-2000
- Applicant
- Meridian Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2002-02-04
- Decision date
- 2002-08-29
- Days to decision
- 206 days
- Clearance type
- Traditional
- Product code
- GZO
- Device class
- 2
- Regulation number
- 882.1540
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Songpa-Gu, Seoul, KR
- Third-party review
- No
- Expedited review
- No
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| MSAS-VANTAGE (K053004) | Biomeridian, Int. | 2006-01-13 |
| EPI-SCAN, MODEL P 100 (K032935) | Edx Epi-Scan, Inc. | 2003-11-20 |
| ASYRA (K023355) | Galloway Technologies, LLC | 2003-06-24 |
| AKUPORT M1 (K020567) | Vibrant Health | 2002-05-02 |
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Recalls involving this device
No recalls on record reference this clearance.