FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
UVA FLUORESCENT TANNING LAMPS
K Number: K813451
·
Decision Jan 28, 1982
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
5
Applicant Total
15
Review Days
49
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Basic Information
- Device Name
- UVA FLUORESCENT TANNING LAMPS
- K Number
- K813451
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5500
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- North American Philips Corp.
- Date Received
- December 10, 1981
- Decision Date
- January 28, 1982
- Product Code
- IOB
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| IOB | Lamp, Infrared, Non Heating | FDA class 2 | Physical Medicine |
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| K830687 | NORELCO ELECTRONIC ANALOG BLOOD PRESS | May 18, 1983 | Substantially Equivalent |
| K830686 | ANEROID BLOOD PRESSURE CUFF #HC1400 | May 18, 1983 | Substantially Equivalent |
| K830684 | NORELCO ELECTRONIC DIGITAL BLOOD PRESS | May 18, 1983 | Substantially Equivalent |
| K811891 | NORELCO MASSAGER PLUS HEAT BELT | Jul 20, 1981 | Substantially Equivalent |
| K811636 | NORELCO ELECTRONIC BLOOD PRESSURE METER | Jun 30, 1981 | Substantially Equivalent |