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FDA 510(k)

PREZAPAK L ARTERIAL BLOOD SAMPLING KIT

K-Number: K801015 · 1980-05-14

ApplicantKimble-Terumo, Inc.
Decision Date1980-05-14
Product CodeGIM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PREZAPAK L ARTERIAL BLOOD SAMPLING KIT is the device name listed in this FDA 510(k) record. The listed applicant is Kimble-Terumo, Inc.. It received FDA 510(k) clearance on 1980-05-14 under 510(k) number K801015. The device is classified under product code GIM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PREZAPAK L ARTERIAL BLOOD SAMPLING KIT?

PREZAPAK L ARTERIAL BLOOD SAMPLING KIT is a medical device that received FDA 510(k) clearance on 1980-05-14. The listed applicant is Kimble-Terumo, Inc.. The 510(k) number is K801015.

When did PREZAPAK L ARTERIAL BLOOD SAMPLING KIT receive FDA 510(k) clearance?

PREZAPAK L ARTERIAL BLOOD SAMPLING KIT received FDA 510(k) clearance on 1980-05-14, under 510(k) number K801015.

Who is the listed applicant for PREZAPAK L ARTERIAL BLOOD SAMPLING KIT?

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

What is the FDA product code for PREZAPAK L ARTERIAL BLOOD SAMPLING KIT?

The FDA product code for PREZAPAK L ARTERIAL BLOOD SAMPLING KIT is GIM.

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 Kimble-Terumo, 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.

K792587VENOJECT AUTOSEP

Related Devices (Code: GIM)

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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Official Source

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

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