FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NORELCO ELECTRONIC ANALOG BLOOD PRESS
K Number: K830687
·
Decision May 18, 1983
Classifications
1
FEI Numbers
420
Registration Numbers
420
Same Product Code
1186
Applicant Total
15
Review Days
75
Basic Information
- Device Name
- NORELCO ELECTRONIC ANALOG BLOOD PRESS
- K Number
- K830687
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1130
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- NORTH AMERICAN PHILIPS CORP.
- Date Received
- March 4, 1983
- Decision Date
- May 18, 1983
- 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 NORTH AMERICAN PHILIPS CORP.
| K Number | Device Name | ||
|---|---|---|---|
| K842486 | ELECTRONIC DIGITAL BP METER HC 3001 | Aug 24, 1984 | Substantially Equivalent |
| K841489 | NORELCO ELECTRONIC DIGITAL BP METER | Apr 10, 1984 | Unknown |
| K833755 | ELECTRONIC DIGITAL FEVER THERMOMETER | Jan 30, 1984 | Substantially Equivalent |
| K830715 | NORELCO VIBRATING BOARD V900 | May 25, 1983 | Substantially Equivalent |
| K830684 | NORELCO ELECTRONIC DIGITAL BLOOD PRESS | May 18, 1983 | Substantially Equivalent |
| K830685 | NORELCO DELUXE DIGITAL BLOOD PRESSURE | May 18, 1983 | Substantially Equivalent |
| K830686 | ANEROID BLOOD PRESSURE CUFF #HC1400 | May 18, 1983 | Substantially Equivalent |
| K813451 | UVA FLUORESCENT TANNING LAMPS | Jan 28, 1982 | Substantially Equivalent |
| K811891 | NORELCO MASSAGER PLUS HEAT BELT | Jul 20, 1981 | Substantially Equivalent |
| K811635 | NORELCO DIGITAL BLOOD PRESSURE METER | Jun 30, 1981 | Substantially Equivalent |