FDA 510(k)
FDA class 2
Substantially Equivalent for Some Indications
🇺🇸 United States
CHEMSPOR
K Number: K844479
·
Decision Nov 25, 1985
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
205
Applicant Total
36
Review Days
371
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Basic Information
- Device Name
- CHEMSPOR
- K Number
- K844479
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.2800
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- American Sterilizer Co.
- Date Received
- November 19, 1984
- Decision Date
- November 25, 1985
- Product Code
- FRC
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FRC | Indicator, Biological Sterilization Process | FDA class 2 | General Hospital |
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Other Clearances by American Sterilizer Co.
| K Number | Device Name | ||
|---|---|---|---|
| K943288 | AMSCO SQ240 SURGICAL LIGHT | Oct 17, 1994 | Substantially Equivalent |
| K931872 | THE EAGLE 3017 100% ETHYLENE OXIDE STERILIZER | Feb 7, 1994 | Substantially Equivalent |
| K922485 | CHEMDI-VHP CHEMICAL INDICATOR | Sep 29, 1993 | Substantially Equivalent |
| K930493 | QUANTUM 3080 SURGICAL TABLE | Jun 22, 1993 | Substantially Equivalent |
| K905816 | ORTHOVISION TABLE | Mar 6, 1991 | Substantially Equivalent |
| K896674 | AMSCO QUANTUM LIGHT | Jan 3, 1990 | Substantially Equivalent |
| K895164 | EAGLE DS | Nov 17, 1989 | Substantially Equivalent |
| K882660 | GENERAL SURGICAL TABLE AND ACCESSORIES | Jul 25, 1988 | Substantially Equivalent |
| K880198 | GEMINI SURGICAL LIGHT | Feb 10, 1988 | Substantially Equivalent |
| K864846 | RADIOGRAPHIC - LEG SECTION | Dec 24, 1986 | Substantially Equivalent |