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FDA 510(k)

QUALISTICK ARTERIAL BLOOD SAMPLER

K-Number: K831034 · 1983-05-18

ApplicantRadiometer America, Inc.
Decision Date1983-05-18
Product CodeCBT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

QUALISTICK ARTERIAL BLOOD SAMPLER is the device name listed in this FDA 510(k) record. The listed applicant is Radiometer America, Inc.. It received FDA 510(k) clearance on 1983-05-18 under 510(k) number K831034. The device is classified under product code CBT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUALISTICK ARTERIAL BLOOD SAMPLER?

QUALISTICK ARTERIAL BLOOD SAMPLER is a medical device that received FDA 510(k) clearance on 1983-05-18. The listed applicant is Radiometer America, Inc.. The 510(k) number is K831034.

When did QUALISTICK ARTERIAL BLOOD SAMPLER receive FDA 510(k) clearance?

QUALISTICK ARTERIAL BLOOD SAMPLER received FDA 510(k) clearance on 1983-05-18, under 510(k) number K831034.

Who is the listed applicant for QUALISTICK ARTERIAL BLOOD SAMPLER?

The FDA 510(k) record lists Radiometer America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QUALISTICK ARTERIAL BLOOD SAMPLER?

The FDA product code for QUALISTICK ARTERIAL BLOOD SAMPLER is CBT.

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Other records listing Radiometer America, Inc. as applicant

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Related Devices (Code: CBT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K071269HEMODRAW ARTERIAL BLOOD SAMPLING SYSTEMSmiths Medical Asd, Inc.K070340SECURE ARTERIAL BLOOD SAMPLING SYSTEMSmiths Medical Asd, Inc.K955663ABC IN-LINE BLOOD SAMPLING KITUtah Medical Products, Inc.K954015ABG POINT LOK NEEDLE PROTECTION DEVICEDevon Industries, Inc.K954035ACTI-FLEX ARTERIAL EXTENSION SETR-Group Intl.K950098NEEDLE SAFETY COVERHammer-Plane, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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