FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
EAGLE DS
K Number: K895164
·
Decision Nov 17, 1989
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
6
Applicant Total
36
Review Days
87
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Basic Information
- Device Name
- EAGLE DS
- K Number
- K895164
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6710
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- American Sterilizer Co.
- Date Received
- August 22, 1989
- Decision Date
- November 17, 1989
- Product Code
- ECG
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- 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 |
|---|---|---|---|
| ECG | Sterilizer, Boiling Water | FDA class 1 | Dental |
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Other Clearances by American Sterilizer Co.
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|---|---|---|---|
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| 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 |
| 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 |
| K844479 | CHEMSPOR | Nov 25, 1985 | Substantially Equivalent for Some Indications |