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FDA 510(k)

DISP. HYPERINFLATION BAG SYSTEM

K-Number: K813317 · 1982-03-12

ApplicantIntec Medical, Inc.
Decision Date1982-03-12
Product CodeNHK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

DISP. HYPERINFLATION BAG SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Intec Medical, Inc.. It received FDA 510(k) clearance on 1982-03-12 under 510(k) number K813317. 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 DISP. HYPERINFLATION BAG SYSTEM?

DISP. HYPERINFLATION BAG SYSTEM is a medical device that received FDA 510(k) clearance on 1982-03-12. The listed applicant is Intec Medical, Inc.. The 510(k) number is K813317.

When did DISP. HYPERINFLATION BAG SYSTEM receive FDA 510(k) clearance?

DISP. HYPERINFLATION BAG SYSTEM received FDA 510(k) clearance on 1982-03-12, under 510(k) number K813317.

Who is the listed applicant for DISP. HYPERINFLATION BAG SYSTEM?

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

What is the FDA product code for DISP. HYPERINFLATION BAG SYSTEM?

The FDA product code for DISP. HYPERINFLATION BAG SYSTEM is NHK.

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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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