FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INFRARAX DEVICE
K Number: K850852
·
Decision Aug 21, 1985
Classifications
1
FEI Numbers
462
Registration Numbers
462
Same Product Code
228
Applicant Total
14
Review Days
173
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Basic Information
- Device Name
- INFRARAX DEVICE
- K Number
- K850852
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5500
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Medicon, Inc.
- Date Received
- March 1, 1985
- Decision Date
- August 21, 1985
- Product Code
- ILY
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- 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 |
|---|---|---|---|
| ILY | Lamp, Infrared, Therapeutic Heating | FDA class 2 | Physical Medicine |
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Other Clearances by Medicon, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K962087 | SERVOTRONIC EC100 SYSTEM | Apr 23, 1997 | Substantially Equivalent |
| K952168 | TITANIUM MANDIBULAR FRACTURE SYSTEM | Jun 22, 1995 | Substantially Equivalent |
| K850855 | TENS GB1001 DEVICE | Jan 9, 1986 | Substantially Equivalent |
| K844702 | GAUZE ASORBABLE | Apr 1, 1985 | Substantially Equivalent |
| K844573 | ABSORBABLE GAUZE PRODUCTS | Mar 5, 1985 | Substantially Equivalent |
| K844574 | WHEELCHAIRS | Feb 21, 1985 | Substantially Equivalent |
| K844705 | SHOE COVERS | Jan 10, 1985 | Substantially Equivalent |
| K844703 | GOWNS, SURGICAL | Jan 10, 1985 | Substantially Equivalent |
| K844704 | CAPS (O.R. NURSE, SURGICAL) | Jan 10, 1985 | Substantially Equivalent |
| K840034 | VACUUM STRETCHER IMMOBILIZER | Feb 27, 1984 | Substantially Equivalent |