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FDA 510(k)

NEWPORT COMPASS EXHALED TIDAL VOLUME MONITOR

K-Number: K931542 · 1993-10-25

ApplicantNewport Medical Instruments, Inc.
Decision Date1993-10-25
Product CodeBZK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

NEWPORT COMPASS EXHALED TIDAL VOLUME MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Newport Medical Instruments, Inc.. It received FDA 510(k) clearance on 1993-10-25 under 510(k) number K931542. The device is classified under product code BZK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEWPORT COMPASS EXHALED TIDAL VOLUME MONITOR?

NEWPORT COMPASS EXHALED TIDAL VOLUME MONITOR is a medical device that received FDA 510(k) clearance on 1993-10-25. The listed applicant is Newport Medical Instruments, Inc.. The 510(k) number is K931542.

When did NEWPORT COMPASS EXHALED TIDAL VOLUME MONITOR receive FDA 510(k) clearance?

NEWPORT COMPASS EXHALED TIDAL VOLUME MONITOR received FDA 510(k) clearance on 1993-10-25, under 510(k) number K931542.

Who is the listed applicant for NEWPORT COMPASS EXHALED TIDAL VOLUME MONITOR?

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

What is the FDA product code for NEWPORT COMPASS EXHALED TIDAL VOLUME MONITOR?

The FDA product code for NEWPORT COMPASS EXHALED TIDAL VOLUME MONITOR is BZK.

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Other records listing Newport Medical Instruments, 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.

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Related Devices (Code: BZK)

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.

K260226ElintMAX Respiratory Monitor (ElintMAX Monitor A1)Amptron Medical, Inc.K192584BEACON Caresystem Model 00002144Mermaid Care A/SK192595ExSpiron 2XiRespiratory MotionK180788Gas Module 3Shenzhen Mindray Bio-Medical Electronics Co., Ltd.K173181ExSpiron 1XiRespiratory Motion, Inc.K162131ExSpiron 1XiRespiratory Motion, 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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