ABL5 BLOOD GAS SYSTEM— 510(k) K935655
Substantially EquivalentRadiometer America, Inc.
FDA 510(k) clearance K935655 for ABL5 BLOOD GAS SYSTEM, Substantially Equivalent on 1994-05-27. Applicant: Radiometer America, Inc.. Device class: 2.
Clearance details
- Applicant
- Radiometer America, Inc.
- Product code
- Code CHL
- Device class
- Class 2
- Regulation
- 21 CFR 862.1120
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Westlake, OH, US
Recent devices under product code CHL
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view all- K153712 — VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification Kit
- K992859 — ABL700 SERIES ANALYZER WITH AUTOCHECK MODULE
- K991417 — ABL 735 ANALYZER
- K982928 — NPT7 SERIES PH/BLOOD GAS AND CO-OXIMETRY SYSTEM
- K980130 — ABL700 SERIES BLOOD GAS , CO-OXIMETRY, ELECTROLYTE & METABOLITE SYSTEM
Adverse events under product code CHL
product code CHL- Death
- 20
- Malfunction
- 999
- Total
- 1,019
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K935655
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K935655.
Data sourced from openFDA. This site is unofficial and independent of the FDA.