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FDA 510(k)

DISPOSABLE NEONATAL VENTILATION CIRCUIT

K-Number: K813384 · 1982-01-07

ApplicantIntec.
Decision Date1982-01-07
Product CodeBZO
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE NEONATAL VENTILATION CIRCUIT is the device name listed in this FDA 510(k) record. The listed applicant is Intec.. It received FDA 510(k) clearance on 1982-01-07 under 510(k) number K813384. 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 DISPOSABLE NEONATAL VENTILATION CIRCUIT?

DISPOSABLE NEONATAL VENTILATION CIRCUIT is a medical device that received FDA 510(k) clearance on 1982-01-07. The listed applicant is Intec.. The 510(k) number is K813384.

When did DISPOSABLE NEONATAL VENTILATION CIRCUIT receive FDA 510(k) clearance?

DISPOSABLE NEONATAL VENTILATION CIRCUIT received FDA 510(k) clearance on 1982-01-07, under 510(k) number K813384.

Who is the listed applicant for DISPOSABLE NEONATAL VENTILATION CIRCUIT?

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

What is the FDA product code for DISPOSABLE NEONATAL VENTILATION CIRCUIT?

The FDA product code for DISPOSABLE NEONATAL VENTILATION CIRCUIT 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 Intec. 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.

K813382DISPOSABLE ADULT ANES. CIRCUITK813383DISPOSABLE TRACH SWIVEL CONNECTOR

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.

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