FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ETHYLENE OXIDE STERILIZ. PARAMETRIC REL.
K Number: K822240
·
Decision Dec 30, 1982
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
3
Applicant Total
13
Review Days
156
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Basic Information
- Device Name
- ETHYLENE OXIDE STERILIZ. PARAMETRIC REL.
- K Number
- K822240
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.3500
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- American Mcgaw
- Date Received
- July 27, 1982
- Decision Date
- December 30, 1982
- Product Code
- KFX
- 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 |
|---|---|---|---|
| KFX | Assembly, Thigh/Knee/Shank/Ankle/Foot, External | FDA class 2 | Physical Medicine |
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Other Clearances by American Mcgaw
| K Number | Device Name | ||
|---|---|---|---|
| K853549 | MCGAW/DROP WATCH FLOW MONITOR | Nov 12, 1985 | Substantially Equivalent |
| K843639 | ADD-A-VIAL SOLUTION TRANSFER DEVICE | Jan 14, 1985 | Substantially Equivalent |
| K843954 | MIXING CONTAINER | Nov 28, 1984 | Substantially Equivalent |
| K841729 | ACCUPRO ENTERAL FEEDING PUMP | Jun 1, 1984 | Substantially Equivalent |
| K840212 | CONCENTRATED PLATELET ADMIN. SET | Mar 6, 1984 | Substantially Equivalent |
| K840388 | PAB IV CONTAINER | Mar 6, 1984 | Substantially Equivalent |
| K831716 | CAPD - CATHETER ADAPTER | Jun 24, 1983 | Substantially Equivalent |
| K820133 | MCGAW FAT EMULSION SET | Apr 6, 1982 | Substantially Equivalent |
| K813092 | ACCUPRO I.V. ADMINISTRATION SET | Dec 31, 1981 | Substantially Equivalent |
| K810683 | CAPD CATHETER ADAPTER | May 8, 1981 | Substantially Equivalent |