Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

TYPE 1 & 2 (HUMIDAIR I & II)

K-Number: K953507 · 1995-09-07

ApplicantIcor AB
Decision Date1995-09-07
Product CodeBYD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

TYPE 1 & 2 (HUMIDAIR I & II) is the device name listed in this FDA 510(k) record. The listed applicant is Icor AB. It received FDA 510(k) clearance on 1995-09-07 under 510(k) number K953507. The device is classified under product code BYD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TYPE 1 & 2 (HUMIDAIR I & II)?

TYPE 1 & 2 (HUMIDAIR I & II) is a medical device that received FDA 510(k) clearance on 1995-09-07. The listed applicant is Icor AB. The 510(k) number is K953507.

When did TYPE 1 & 2 (HUMIDAIR I & II) receive FDA 510(k) clearance?

TYPE 1 & 2 (HUMIDAIR I & II) received FDA 510(k) clearance on 1995-09-07, under 510(k) number K953507.

Who is the listed applicant for TYPE 1 & 2 (HUMIDAIR I & II)?

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 TYPE 1 & 2 (HUMIDAIR I & II)?

The FDA product code for TYPE 1 & 2 (HUMIDAIR I & II) is BYD.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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)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 FILTERSK940041COLIBRIK941436AFH, AFH FLEX, AFH/T, AFH/T FLEX, AF

View all 16 devices →

Related Devices (Code: BYD)

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.

K955008HEAT & MOISTURE EXCHANGERIntertech Resources, Inc.K954194DISPOSABLE HME/FILTEREngstrom MedicalK953580HEAT MOISTURE EXCHANGERIntertech Resources, Inc.K953544HUMID-VENT 2 LIGHT/HUMID-VENT 2 PORT LIGHTGibeck, Inc.K953620WARM N WET HMEF W/LUER ADAPTERHospitak, Inc.K953540EEEEdentec 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.

↑