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FDA 510(k)

NEONATAL BREATHING CIRCUIT SYSTEM

K-Number: K801087 · 1980-05-23

ApplicantIsothermal Systems, Inc.
Decision Date1980-05-23
Product CodeBZO
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

NEONATAL BREATHING CIRCUIT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Isothermal Systems, Inc.. It received FDA 510(k) clearance on 1980-05-23 under 510(k) number K801087. 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 NEONATAL BREATHING CIRCUIT SYSTEM?

NEONATAL BREATHING CIRCUIT SYSTEM is a medical device that received FDA 510(k) clearance on 1980-05-23. The listed applicant is Isothermal Systems, Inc.. The 510(k) number is K801087.

When did NEONATAL BREATHING CIRCUIT SYSTEM receive FDA 510(k) clearance?

NEONATAL BREATHING CIRCUIT SYSTEM received FDA 510(k) clearance on 1980-05-23, under 510(k) number K801087.

Who is the listed applicant for NEONATAL BREATHING CIRCUIT SYSTEM?

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

What is the FDA product code for NEONATAL BREATHING CIRCUIT SYSTEM?

The FDA product code for NEONATAL BREATHING CIRCUIT SYSTEM 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 Isothermal Systems, 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.

K771510SERVO-PAK MOLEL 0030

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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