FDA 510(k)

CM 7000MR

K-Number: K890010 · 1989-06-12

Decision Date1989-06-12

Product CodeCAP

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

CM 7000MR is the device name listed in this FDA 510(k) record. The listed applicant is Trudell Medical. It received FDA 510(k) clearance on 1989-06-12 under 510(k) number K890010. The device is classified under product code CAP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CM 7000MR?

CM 7000MR is a medical device that received FDA 510(k) clearance on 1989-06-12. The listed applicant is Trudell Medical. The 510(k) number is K890010.

When did CM 7000MR receive FDA 510(k) clearance?

CM 7000MR received FDA 510(k) clearance on 1989-06-12, under 510(k) number K890010.

Who is the listed applicant for CM 7000MR?

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

What is the FDA product code for CM 7000MR?

The FDA product code for CM 7000MR is CAP.

Other records listing Trudell Medical 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.

K982181TRUMIST BREATH ACTUATED DISPOSABLE NEBULIZER K982179TRUMIST AIR ENTRAINED DISPOSABLE NEBULIZER

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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.