QUALISTICK ARTERIAL BLOOD SAMPLER— 510(k) K831034
Substantially EquivalentRadiometer America, Inc.
FDA 510(k) clearance K831034 for QUALISTICK ARTERIAL BLOOD SAMPLER, Substantially Equivalent on 1983-05-18. Applicant: Radiometer America, Inc.. Device class: 1.
Clearance details
- Applicant
- Radiometer America, Inc.
- Product code
- Code CBT
- Device class
- Class 1
- Regulation
- 21 CFR 868.1100
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mentor, OH, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.