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FDA 510(k)

ADAPTOR HR-3000 REUSE

K-Number: K841153 · 1984-07-16

ApplicantColorado Medical, Inc.
Decision Date1984-07-16
Product CodeLIF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ADAPTOR HR-3000 REUSE 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 1984-07-16 under 510(k) number K841153. The device is classified under product code LIF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADAPTOR HR-3000 REUSE?

ADAPTOR HR-3000 REUSE is a medical device that received FDA 510(k) clearance on 1984-07-16. The listed applicant is Colorado Medical, Inc.. The 510(k) number is K841153.

When did ADAPTOR HR-3000 REUSE receive FDA 510(k) clearance?

ADAPTOR HR-3000 REUSE received FDA 510(k) clearance on 1984-07-16, under 510(k) number K841153.

Who is the listed applicant for ADAPTOR HR-3000 REUSE?

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 ADAPTOR HR-3000 REUSE?

The FDA product code for ADAPTOR HR-3000 REUSE is LIF.

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 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.

K870471MODIFIED HR-3000 REUSE ADAPTORK870689HR-3000 REUSE ADAPTORK863471COLORADO MEDICAL MODEL PTC 1000K853735COLORADO MEDICAL MODEL CTM-3000K830190AHR-3000 RE-USE ADAPTOR

Related Devices (Code: LIF)

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.

K091360CLEARFLUX DIALYZER REPROCESSING SYSTEMNovaflux TechnologiesK043126ASSIST HEADER CLEANERAlcavis International, Inc.K040660STERICHEK GLUTARALDEHYDE REAGENT STRIPSHach CompanyK033505RENACLEAN SH DIALYZER CLEANING SYSTEMMinntech Corp.K024076MAKY 21.1 DIALYZER REPROCESSING SYSTEMHdc Maquinolas, LLCK013713ARM AUTOMATIC REPROCESSING MACHINEAlcavis International Incorporated

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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