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FDA 510(k)

INTERTECH NEWBORN HYPERINFLATION BAG SYSTEM

K-Number: K894612 · 1989-09-08

ApplicantIntertech Resources, Inc.
Decision Date1989-09-08
Product CodeNHK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

INTERTECH NEWBORN HYPERINFLATION BAG SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Intertech Resources, Inc.. It received FDA 510(k) clearance on 1989-09-08 under 510(k) number K894612. The device is classified under product code NHK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTERTECH NEWBORN HYPERINFLATION BAG SYSTEM?

INTERTECH NEWBORN HYPERINFLATION BAG SYSTEM is a medical device that received FDA 510(k) clearance on 1989-09-08. The listed applicant is Intertech Resources, Inc.. The 510(k) number is K894612.

When did INTERTECH NEWBORN HYPERINFLATION BAG SYSTEM receive FDA 510(k) clearance?

INTERTECH NEWBORN HYPERINFLATION BAG SYSTEM received FDA 510(k) clearance on 1989-09-08, under 510(k) number K894612.

Who is the listed applicant for INTERTECH NEWBORN HYPERINFLATION BAG SYSTEM?

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

What is the FDA product code for INTERTECH NEWBORN HYPERINFLATION BAG SYSTEM?

The FDA product code for INTERTECH NEWBORN HYPERINFLATION BAG SYSTEM is NHK.

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Other records listing Intertech Resources, 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.

K9613181ST RESPONSE DISPOSABLE MANOMETERK955008HEAT & MOISTURE EXCHANGERK953580HEAT MOISTURE EXCHANGERK952223XENON GAS BREATHING CIRCUITK952169SAFE RESPONSE MOUTH-TO-MASK RESUSCITATOR, PEDIATRICK952062PFT FILTER

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Related Devices (Code: NHK)

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.

K092687VENTI.PLUS HYPERINFLATION BAG SYSTEM WITH PRESSURE MANOMETERA Plus MedicalK020281MODIFICATION TO VENTLAB HYPERINFLATION BAG SYSTEMVentlab Corp.K013308VENTLAB HYPERINFLATION BAG SYSTEMVentlab Corp.K001714MERCURY MEDICAL HYPERINFLATION BAG SYSTEM, MODEL 83-900-0149Mercury MedicalK970785SIMS HYPERINFLATION BAG SYSTEMSimsK952214SIMS INTERTECH HYPERINFLATION BAG SYSTEMIntertech Resources, 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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