FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇰 Denmark
ABL-700 SERIES, MODEL ABL 7XX (VARIOUS MODELS)
K Number: K002290
·
Decision Sep 13, 2000
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
187
Applicant Total
2
Review Days
48
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Basic Information
- Device Name
- ABL-700 SERIES, MODEL ABL 7XX (VARIOUS MODELS)
- K Number
- K002290
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1120
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Radiometer Medical A/S
- Date Received
- July 27, 2000
- Decision Date
- September 13, 2000
- 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 Radiometer Medical A/S
| K Number | Device Name | ||
|---|---|---|---|
| K001866 | TCM400 | Dec 7, 2000 | Substantially Equivalent |