FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO STAT PROFILE PHOX BLOOD GAS ANALYZER (K980991)
K Number: K982277
·
Decision Jul 22, 1998
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
187
Applicant Total
89
Review Days
23
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Basic Information
- Device Name
- MODIFICATION TO STAT PROFILE PHOX BLOOD GAS ANALYZER (K980991)
- K Number
- K982277
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1120
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Nova Biomedical Corp.
- Date Received
- June 29, 1998
- Decision Date
- July 22, 1998
- 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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| K070068 | NOVA STATSENSOR CREATININE HOSPITAL METER, CONTROL SOLUTIONS,LINEARITY SOLUTIONS, AND TEST STRIPS | May 7, 2007 | Substantially Equivalent |
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| K061830 | STAT PROFILE CRITICAL CARE XPRESS (CCX), MODEL 1+ | Nov 1, 2006 | Substantially Equivalent |
| K060345 | NOVA STATSTRIP GLUCOSE HOSPITAL METER, STATSTRIP CONTROL SOLUTIONS | Apr 28, 2006 | Substantially Equivalent |
| K041016 | NOVA GLUCOSE LOW/HIGH LEVEL CONTROL SOLUTIONS | May 7, 2004 | Substantially Equivalent |