FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
ABR-2000
K Number: K020360
·
Decision Aug 29, 2002
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
25
Applicant Total
7
Review Days
206
Basic Information
- Device Name
- ABR-2000
- K Number
- K020360
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1540
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MERIDIAN CO., LTD.
- Date Received
- February 4, 2002
- Decision Date
- August 29, 2002
- Product Code
- GZO
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GZO | Device, Galvanic Skin Response Measurement | FDA class 2 | Neurology |
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Other Clearances by MERIDIAN CO., LTD.
| K Number | Device Name | ||
|---|---|---|---|
| K102375 | LUCIA | Feb 25, 2011 | Substantially Equivalent |
| K081962 | LAPEX BCS | Dec 29, 2008 | Substantially Equivalent |
| K034009 | LAPEX 2000 | Jan 21, 2005 | Substantially Equivalent |
| K023238 | MCPULSE | Feb 19, 2003 | Substantially Equivalent |
| K010897 | MERIDIAN-PORTABLE | Jun 19, 2001 | Substantially Equivalent |
| K001347 | MERIDIAN-II AND MERDIAN-PLUS | Nov 3, 2000 | Substantially Equivalent |