FDA 510(k)
FDA class 2
Substantially Equivalent for Some Indications
🇺🇸 United States
ORTHO TECH CRYOLOGIC SYSTEM
K Number: K940429
·
Decision Jul 12, 1994
Classifications
1
FEI Numbers
123
Registration Numbers
123
Same Product Code
92
Applicant Total
2
Review Days
162
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Basic Information
- Device Name
- ORTHO TECH CRYOLOGIC SYSTEM
- K Number
- K940429
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5720
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Orthopedic Technology, Inc.
- Date Received
- January 31, 1994
- Decision Date
- July 12, 1994
- Product Code
- ILO
- 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 |
|---|---|---|---|
| ILO | Pack, Hot Or Cold, Water Circulating | FDA class 2 | Physical Medicine |
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Other Clearances by Orthopedic Technology, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K843780 | VENT-A-CAST | Nov 14, 1984 | Substantially Equivalent |