FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AVL BLOOD GAS INSTRUMENT MODEL 939
K Number: K771147
·
Decision Sep 15, 1977
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
186
Applicant Total
2
Review Days
80
Basic Information
- Device Name
- AVL BLOOD GAS INSTRUMENT MODEL 939
- K Number
- K771147
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1120
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- JONES MEDICAL INSTRUMENT CO.
- Date Received
- June 27, 1977
- Decision Date
- September 15, 1977
- Product Code
- CHL
- 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 |
|---|---|---|---|
| CHL | Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | FDA class 2 | Clinical Chemistry |
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Other Clearances by JONES MEDICAL INSTRUMENT CO.
| K Number | Device Name | ||
|---|---|---|---|
| K812001 | OSCILLAIRE | Aug 20, 1981 | Substantially Equivalent |