FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MEDICOR QUALITY CONTROL BUFFER
K Number: K791287
·
Decision Aug 16, 1979
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
66
Applicant Total
14
Review Days
37
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Basic Information
- Device Name
- MEDICOR QUALITY CONTROL BUFFER
- K Number
- K791287
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Medicor USA , Ltd.
- Date Received
- July 10, 1979
- Decision Date
- August 16, 1979
- 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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|---|---|---|---|
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| K860025 | MODEL MS-325 RADIOGRAPHIC X-RAY GENERATOR | May 7, 1986 | Substantially Equivalent |
| K850761 | MODEL PCX/EMY 525A MICROPROCESSSOR CONTROL X-RAY C | Sep 19, 1985 | Substantially Equivalent |
| K851358 | MODEL BION 2/TYPE 90 ROOM IONIZER | Jul 1, 1985 | Substantially Equivalent |
| K851094 | MODEL BION 1/TYPE 1084T CAR IONIZER | Jun 19, 1985 | Substantially Equivalent |
| K843335 | FLOOR MOUNTED X-RAY TUBESTAND | Nov 27, 1984 | Substantially Equivalent |
| K840227 | UROLIX-3 UROLOGICAL TABLE | Mar 23, 1984 | Substantially Equivalent |
| K840225 | C-ARM CEILING CRANE FT-2 | Mar 22, 1984 | Substantially Equivalent |
| K840226 | MOTOR TILTED EXAM. TABLE UV-56 | Mar 16, 1984 | Substantially Equivalent |