FDA 510(k)
FDA class 2
Substantially Equivalent
🇭🇰 Hong Kong
AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR
K Number: K942336
·
Decision Nov 28, 1994
Classifications
1
FEI Numbers
428
Registration Numbers
428
Same Product Code
1216
Applicant Total
5
Review Days
196
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Basic Information
- Device Name
- AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR
- K Number
- K942336
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1130
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Integrated Display Technology, Ltd.
- Date Received
- May 16, 1994
- Decision Date
- November 28, 1994
- Product Code
- DXN
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | FDA class 2 | Cardiovascular |
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Other Clearances by Integrated Display Technology, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K951977 | DIGITAL BLOOD PRESSURE METER - MODEL NO.: BPM883 | Oct 24, 1995 | Substantially Equivalent |
| K941490 | BLOOD PRESSURE METER MODEL NO. BPM888 | Nov 29, 1994 | Substantially Equivalent |
| K894627 | BT-338N ELECTRONIC CLINICAL THERMOMETER | Oct 23, 1989 | Substantially Equivalent |
| K853130 | INTEGRATED DISPLAY TECHNOLOGY LTD. | Nov 8, 1985 | Substantially Equivalent |