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FDA 510(k)

ICOR CALARIC MEASUREMENT UNIT (CMU)

K-Number: K854927 · 1986-03-27

ApplicantIcor AB
Decision Date1986-03-27
Product CodeBZL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ICOR CALARIC MEASUREMENT UNIT (CMU) is the device name listed in this FDA 510(k) record. The listed applicant is Icor AB. It received FDA 510(k) clearance on 1986-03-27 under 510(k) number K854927. The device is classified under product code BZL. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ICOR CALARIC MEASUREMENT UNIT (CMU)?

ICOR CALARIC MEASUREMENT UNIT (CMU) is a medical device that received FDA 510(k) clearance on 1986-03-27. The listed applicant is Icor AB. The 510(k) number is K854927.

When did ICOR CALARIC MEASUREMENT UNIT (CMU) receive FDA 510(k) clearance?

ICOR CALARIC MEASUREMENT UNIT (CMU) received FDA 510(k) clearance on 1986-03-27, under 510(k) number K854927.

Who is the listed applicant for ICOR CALARIC MEASUREMENT UNIT (CMU)?

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

What is the FDA product code for ICOR CALARIC MEASUREMENT UNIT (CMU)?

The FDA product code for ICOR CALARIC MEASUREMENT UNIT (CMU) is BZL.

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Other records listing Icor AB 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.

K954402ET-TUBE PLACEMENT DETECTOR (WITH COLIBRI INDICATOR)K953507TYPE 1 & 2 (HUMIDAIR I & II)K952325ET TUBE PLACEMENT DETECTOR (WITH COLIBRI INDICATOR)K952823FHB, FHB-T WITH OR WITHOUT FLEXTUBE HFH, HFH-T, AFA, AFH-T WITH OR WITHOUT FLEXRTUBEK941987HEAT AND MOISTURE EXCHANGERS AND FILTERSK940041COLIBRI

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Related Devices (Code: BZL)

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.

K200076Breezing MedTf Health Co.K190561NICU V'02Cosmed Nordic ApsK110810ANASCIENT BREATH MONITORInvoy Technologies, LLCK093080METAPHOR METABOLIC MONITORTreymed, Inc.K071533FITMATE SERIESCosmed SrlK070858EXPRESS SERIESMedical Graphics Corp.

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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