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)

HALA'TUS 1 OXYGENATOR

K-Number: K903504 · 1991-01-28

ApplicantThe Henry G. Dietz Co., Inc.
Decision Date1991-01-28
Product CodeNFB
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

HALA'TUS 1 OXYGENATOR is the device name listed in this FDA 510(k) record. The listed applicant is The Henry G. Dietz Co., Inc.. It received FDA 510(k) clearance on 1991-01-28 under 510(k) number K903504. The device is classified under product code NFB. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HALA'TUS 1 OXYGENATOR?

HALA'TUS 1 OXYGENATOR is a medical device that received FDA 510(k) clearance on 1991-01-28. The listed applicant is The Henry G. Dietz Co., Inc.. The 510(k) number is K903504.

When did HALA'TUS 1 OXYGENATOR receive FDA 510(k) clearance?

HALA'TUS 1 OXYGENATOR received FDA 510(k) clearance on 1991-01-28, under 510(k) number K903504.

Who is the listed applicant for HALA'TUS 1 OXYGENATOR?

The FDA 510(k) record lists The Henry G. Dietz Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HALA'TUS 1 OXYGENATOR?

The FDA product code for HALA'TUS 1 OXYGENATOR is NFB.

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 The Henry G. Dietz Co., 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.

K942581BES - BREATH EXPOSURE SYNCHRONIZER

Related Devices (Code: NFB)

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.

K250322Respond OC Conserving Regulator (130-0800)Responsive RespiratoryK220591ProximaDynasthetics, LLCK221014Effortless Oxygen Conserver System Models Effortless Pro and Effortless MobileEffortless Oxygen, LLCK200401ApogeeIncoba Ltd D/B/A DynarisK151506Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen CannulaSalter LabsK131023THERAFLOW SINGLE LUMEN AND THERAFLOW DUAL LUMENMedical Products, LLC

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.

↑