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FDA 510(k)

ORGANON ARTERIAL BLOOD SAMPLER

K-Number: K801435 · 1980-07-18

ApplicantAkzona, Inc.
Decision Date1980-07-18
Product CodeCBT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ORGANON ARTERIAL BLOOD SAMPLER is the device name listed in this FDA 510(k) record. The listed applicant is Akzona, Inc.. It received FDA 510(k) clearance on 1980-07-18 under 510(k) number K801435. 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 ORGANON ARTERIAL BLOOD SAMPLER?

ORGANON ARTERIAL BLOOD SAMPLER is a medical device that received FDA 510(k) clearance on 1980-07-18. The listed applicant is Akzona, Inc.. The 510(k) number is K801435.

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

ORGANON ARTERIAL BLOOD SAMPLER received FDA 510(k) clearance on 1980-07-18, under 510(k) number K801435.

Who is the listed applicant for ORGANON ARTERIAL BLOOD SAMPLER?

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

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

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

Related Clinical Trials

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.

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Other records listing Akzona, Inc. as applicant

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.

K772119TIME WATCH

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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