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FDA 510(k)

COLORADO MEDICAL MODEL CTM-3000

K-Number: K853735 · 1985-10-04

Decision Date1985-10-04
Product CodeFIZ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

COLORADO MEDICAL MODEL CTM-3000 is the device name listed in this FDA 510(k) record. The listed applicant is Colorado Medical, Inc.. It received FDA 510(k) clearance on 1985-10-04 under 510(k) number K853735. The device is classified under product code FIZ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COLORADO MEDICAL MODEL CTM-3000?

COLORADO MEDICAL MODEL CTM-3000 is a medical device that received FDA 510(k) clearance on 1985-10-04. The listed applicant is Colorado Medical, Inc.. The 510(k) number is K853735.

When did COLORADO MEDICAL MODEL CTM-3000 receive FDA 510(k) clearance?

COLORADO MEDICAL MODEL CTM-3000 received FDA 510(k) clearance on 1985-10-04, under 510(k) number K853735.

Who is the listed applicant for COLORADO MEDICAL MODEL CTM-3000?

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

What is the FDA product code for COLORADO MEDICAL MODEL CTM-3000?

The FDA product code for COLORADO MEDICAL MODEL CTM-3000 is FIZ.

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.

Other records listing Colorado Medical, 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.

Related Devices (Code: FIZ)

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.

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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