FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NORELCO ELECTRNIC DIGITAL BLOOD PRESSURE METER
K Number: K855177
·
Decision Nov 7, 1986
Classifications
1
FEI Numbers
428
Registration Numbers
428
Same Product Code
1216
Applicant Total
11
Review Days
316
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Basic Information
- Device Name
- NORELCO ELECTRNIC DIGITAL BLOOD PRESSURE METER
- K Number
- K855177
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1130
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Philips Park
- Date Received
- December 26, 1985
- Decision Date
- November 7, 1986
- 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 Philips Park
| K Number | Device Name | ||
|---|---|---|---|
| K854279 | NORELCO ELECTRONIC DIGITAL BP METER HC3030 | Nov 17, 1986 | Substantially Equivalent |
| K855048 | NORELCO DIGITAL BLOOD PRESSURE METER HC3001 | Nov 17, 1986 | Substantially Equivalent |
| K854023 | NORELCO ELECTRONIC DIGITAL BP METER HC3501 | Mar 26, 1986 | Substantially Equivalent |
| K854800 | NORELCO DIGITAL THERMOMETER, MODEL HT 960 | Jan 9, 1986 | Substantially Equivalent |
| K852128 | NORELCO ELECTRONIC DIGITAL BP METER HC3501 | Sep 12, 1985 | Substantially Equivalent |
| K852037 | NORELCO ELECTRONIC DIGITAL BLOOD PRESSURE METER | Jun 11, 1985 | Substantially Equivalent |
| K851049 | NORELCO BLOOD PRESSURE METER | May 16, 1985 | Substantially Equivalent |
| K851075 | NORELCO DIGITAL MODEL 970 THERMOMETER | Apr 4, 1985 | Substantially Equivalent |
| K851010 | NORELCO DIGITAL MODEL 987 THERMOMETER | Apr 4, 1985 | Substantially Equivalent |
| K833753 | AC ADAPTERS FOR BLOOD PRESSURE METERS | Jan 30, 1984 | Substantially Equivalent |