FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
EUROTROL GAS - ISE CONTROL
K Number: K955340
·
Decision Dec 26, 1995
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
66
Applicant Total
5
Review Days
36
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Basic Information
- Device Name
- EUROTROL GAS - ISE CONTROL
- K Number
- K955340
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Direct Solutions
- Date Received
- November 20, 1995
- Decision Date
- December 26, 1995
- Product Code
- JJS
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| JJS | Controls For Blood-Gases, (Assayed And Unassayed) | FDA class 1 | Clinical Chemistry |
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