Modification to Stat Profile Phox Blood Gas Analyzer (K980991)
FDA 510(k) K982277 · Nova Biomedical Corp.
510(k) numberK982277
Submission
- Device name
- Modification to Stat Profile Phox Blood Gas Analyzer (K980991)
- Applicant
- Nova Biomedical Corp.
Walham, MA, US - Received
- June 29, 1998
- Decision date
- July 22, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CHL – Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1120
- Specialty
- Clinical Chemistry
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Questions and answers
When was Modification to Stat Profile Phox Blood Gas Analyzer (K980991) cleared by the FDA?
Modification to Stat Profile Phox Blood Gas Analyzer (K980991) (K982277) received a 510(k) decision of Substantially Equivalent on July 22, 1998, 23 days after the submission was received.
What is the product code of K982277?
The FDA product code is CHL – Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph, a Class II (moderate risk) device regulated under 21 CFR 862.1120.