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FDA 510(k)

NEWPORT ELECTRONIC MANOMETER

K-Number: K941309 · 1995-03-06

ApplicantNewport Medical Instruments, Inc.
Decision Date1995-03-06
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent - Subject to Tracking Reg.

Device Summary

NEWPORT ELECTRONIC MANOMETER 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 1995-03-06 under 510(k) number K941309. The device is classified under product code CBK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent - Subject to Tracking Reg..

Frequently Asked Questions

What is the NEWPORT ELECTRONIC MANOMETER?

NEWPORT ELECTRONIC MANOMETER is a medical device that received FDA 510(k) clearance on 1995-03-06. The listed applicant is Newport Medical Instruments, Inc.. The 510(k) number is K941309.

When did NEWPORT ELECTRONIC MANOMETER receive FDA 510(k) clearance?

NEWPORT ELECTRONIC MANOMETER received FDA 510(k) clearance on 1995-03-06, under 510(k) number K941309.

Who is the listed applicant for NEWPORT ELECTRONIC MANOMETER?

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 ELECTRONIC MANOMETER?

The FDA product code for NEWPORT ELECTRONIC MANOMETER is CBK.

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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.

K121891NEWPORT AURA VENTILATORK111146NEWPORT HT70 VENTILATORK101803NEWPORT E360 VENTILATORK090888NEWPORT HT70 FAMILY OF VENTILATORSK082724NEWPORT HTS50 VENTILATOR WITH DUAL PAC BATTERY SYSTEMK061094NEWPORT E500 WAVE VENTILATOR

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Related Devices (Code: CBK)

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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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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