FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
FUZZY AUTOMATIC BLOOD PRESSURE MONITOR MODELS MD-750, MD-770, MD-800
K Number: K992328
·
Decision Jul 21, 1999
Classifications
1
FEI Numbers
428
Registration Numbers
428
Same Product Code
1216
Applicant Total
4
Review Days
9
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Basic Information
- Device Name
- FUZZY AUTOMATIC BLOOD PRESSURE MONITOR MODELS MD-750, MD-770, MD-800
- K Number
- K992328
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1130
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Meditec Co., Ltd.
- Date Received
- July 12, 1999
- Decision Date
- July 21, 1999
- Product Code
- DXN
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | FDA class 2 | Cardiovascular |
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Other Clearances by Meditec Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K041789 | NONINVASIVE BLOOD PRESSURE MONITOR, MODELS MD-880B AND MD-900T | Jul 15, 2004 | Substantially Equivalent |
| K002655 | DIGITAL BLOOD PRESSURE MONITOR, MODEL MD-550 | Sep 6, 2000 | Substantially Equivalent |
| K990380 | (1) DIGITAL BLOOD PRESSURE MONITOR, MODEL MD-250; (2) FULLY AUTOMATIC BLOOD PRESSURE MONITOR, MODEL MD-700 | Feb 22, 1999 | Substantially Equivalent |