FDA 510(k)

MODUFLEX NEONATAL VENTILATOR SET

K-Number: K823479 · 1982-12-15

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic

Decision Date1982-12-15

Product CodeBZO

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

MODUFLEX NEONATAL VENTILATOR SET is the device name listed in this FDA 510(k) record. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. It received FDA 510(k) clearance on 1982-12-15 under 510(k) number K823479. 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 MODUFLEX NEONATAL VENTILATOR SET?

MODUFLEX NEONATAL VENTILATOR SET is a medical device that received FDA 510(k) clearance on 1982-12-15. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K823479.

When did MODUFLEX NEONATAL VENTILATOR SET receive FDA 510(k) clearance?

MODUFLEX NEONATAL VENTILATOR SET received FDA 510(k) clearance on 1982-12-15, under 510(k) number K823479.

Who is the listed applicant for MODUFLEX NEONATAL VENTILATOR SET?

The FDA 510(k) record lists Bd Becton Dickinson Vacutainer Systems Preanalytic as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODUFLEX NEONATAL VENTILATOR SET?

The FDA product code for MODUFLEX NEONATAL VENTILATOR SET 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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Bd Becton Dickinson Vacutainer Systems Preanalytic as applicant

K003062BACTEC MGIT 960 SIR KITS K0035530.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE K003461BD VACUTAINER PASSIVE SHIELDING BLOOD COLLECTION NEEDLE K002938B-D ULTRA-FINE III PEN NEEDLE; MODEL 31G X 3/16 K001364BD DIRECTIGEN FLU A+B K000762MOXIFLOXACIN, 5 UG, BBL SENSI-DISC

View all 632 devices →

Related Devices (Code: BZO)

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.