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FDA 510(k)

NEWPORT VENTILATOR MODEL E-100

K-Number: K852108 · 1985-09-18

ApplicantNewport Medical Instruments, Inc.
Decision Date1985-09-18
Product Code
DecisionSubstantially Equivalent

Device Summary

NEWPORT VENTILATOR MODEL E-100 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 1985-09-18 under 510(k) number K852108. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEWPORT VENTILATOR MODEL E-100?

NEWPORT VENTILATOR MODEL E-100 is a medical device that received FDA 510(k) clearance on 1985-09-18. The listed applicant is Newport Medical Instruments, Inc.. The 510(k) number is K852108.

When did NEWPORT VENTILATOR MODEL E-100 receive FDA 510(k) clearance?

NEWPORT VENTILATOR MODEL E-100 received FDA 510(k) clearance on 1985-09-18, under 510(k) number K852108.

Who is the listed applicant for NEWPORT VENTILATOR MODEL E-100?

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

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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

View all 22 devices →

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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