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FDA 510(k)

CMS 8000

K-Number: K853096 · 1986-01-22

ApplicantPhysio-Control Corp.
Decision Date1986-01-22
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CMS 8000 is the device name listed in this FDA 510(k) record. The listed applicant is Physio-Control Corp.. It received FDA 510(k) clearance on 1986-01-22 under 510(k) number K853096. The device is classified under product code DXH. It was reviewed by the CV advisory panel. Product code DXH falls under the category of Hematology, which includes devices for blood cell counting, coagulation testing, and hemoglobin analysis. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CMS 8000?

CMS 8000 is a medical device that received FDA 510(k) clearance on 1986-01-22. The listed applicant is Physio-Control Corp.. The 510(k) number is K853096.

When did CMS 8000 receive FDA 510(k) clearance?

CMS 8000 received FDA 510(k) clearance on 1986-01-22, under 510(k) number K853096.

Who is the listed applicant for CMS 8000?

The FDA 510(k) record lists Physio-Control Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CMS 8000?

The FDA product code for CMS 8000 is DXH. This falls under the Hematology category.

Other records listing Physio-Control Corp. 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.

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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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