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)

TUBE, INHALER OXYGEN

K-Number: K935582 · 1994-01-14

ApplicantPuritas Health Care, Inc.
Decision Date1994-01-14
Product CodeBZO
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

TUBE, INHALER OXYGEN is the device name listed in this FDA 510(k) record. The listed applicant is Puritas Health Care, Inc.. It received FDA 510(k) clearance on 1994-01-14 under 510(k) number K935582. The device is classified under product code BZO. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TUBE, INHALER OXYGEN?

TUBE, INHALER OXYGEN is a medical device that received FDA 510(k) clearance on 1994-01-14. The listed applicant is Puritas Health Care, Inc.. The 510(k) number is K935582.

When did TUBE, INHALER OXYGEN receive FDA 510(k) clearance?

TUBE, INHALER OXYGEN received FDA 510(k) clearance on 1994-01-14, under 510(k) number K935582.

Who is the listed applicant for TUBE, INHALER OXYGEN?

The FDA 510(k) record lists Puritas Health Care, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TUBE, INHALER OXYGEN?

The FDA product code for TUBE, INHALER OXYGEN is BZO.

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 Puritas Health Care, 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.

K942339SKIN NEUVEAU SCAR TREATMENTK941197SILK*SKIN SCAR TREATMENTK935600TRACHEAL SUCTION CATHETERK935531OP-FLEX SUMP SUCTION SET WITH DIFFUSER TIPK940074Y-TYPE BLOOD ADMINISTRATION SETK940054MEASURED VOLUME SOLUTION ADMINISTRATION SET

View all 24 devices →

Related Devices (Code: BZO)

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.

K953784UNICOR, INC. CORRUGATED TUBINGUnicor, Inc.K953785UNICOR, INC. VENTILATOR HOSESUnicor, Inc.K952011PRIMA BREATHING BAGSPrima, Inc.K952022PRIMA VOLUMN VENTILATORSSPrima, Inc.K952010PRIMA VENTILATOR HOSESPrima, Inc.K952012PRIMA CUSTOM ANESTESIA CIRCUITPrima, 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.

↑