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)

SAF T FLO VENTILATOR TUBING

K-Number: K850703 · 1985-03-25

ApplicantBivona Medical Technologies
Decision Date1985-03-25
Product CodeBZO
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SAF T FLO VENTILATOR TUBING is the device name listed in this FDA 510(k) record. The listed applicant is Bivona Medical Technologies. It received FDA 510(k) clearance on 1985-03-25 under 510(k) number K850703. 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 SAF T FLO VENTILATOR TUBING?

SAF T FLO VENTILATOR TUBING is a medical device that received FDA 510(k) clearance on 1985-03-25. The listed applicant is Bivona Medical Technologies. The 510(k) number is K850703.

When did SAF T FLO VENTILATOR TUBING receive FDA 510(k) clearance?

SAF T FLO VENTILATOR TUBING received FDA 510(k) clearance on 1985-03-25, under 510(k) number K850703.

Who is the listed applicant for SAF T FLO VENTILATOR TUBING?

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

What is the FDA product code for SAF T FLO VENTILATOR TUBING?

The FDA product code for SAF T FLO VENTILATOR TUBING 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 Bivona Medical Technologies 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.

K952700SUPERSLICKK942025BURGET NASAL STENTK944178BIVONA FLEXTEND PEDIATRIC & NEONATAL TRACHEOSTROMY TUBESK935053BIVONA NASAL TURBINATE STENTK933398BIVONA ILLUMINATED ENDOTRACHEAL TUBEK931749BIVONA(R) ICU ENDOTRACHEAL TUBE

View all 50 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.

↑