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)

BREATH-EASY

K-Number: K881308 · 1988-05-17

ApplicantIcor AB
Decision Date1988-05-17
Product CodeBYD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BREATH-EASY is the device name listed in this FDA 510(k) record. The listed applicant is Icor AB. It received FDA 510(k) clearance on 1988-05-17 under 510(k) number K881308. 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 BREATH-EASY?

BREATH-EASY is a medical device that received FDA 510(k) clearance on 1988-05-17. The listed applicant is Icor AB. The 510(k) number is K881308.

When did BREATH-EASY receive FDA 510(k) clearance?

BREATH-EASY received FDA 510(k) clearance on 1988-05-17, under 510(k) number K881308.

Who is the listed applicant for BREATH-EASY?

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 BREATH-EASY?

The FDA product code for BREATH-EASY 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)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

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.K953507TYPE 1 & 2 (HUMIDAIR I & II)Icor ABK953544HUMID-VENT 2 LIGHT/HUMID-VENT 2 PORT LIGHTGibeck, Inc.K953620WARM N WET HMEF W/LUER ADAPTERHospitak, Inc.

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.

↑