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FDA 510(k)

HYPER-INFLATION BAG

K-Number: K942571 · 1994-06-10

ApplicantMed-Plastics Intl., Inc.
Decision Date1994-06-10
Product CodeNHK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

HYPER-INFLATION BAG is the device name listed in this FDA 510(k) record. The listed applicant is Med-Plastics Intl., Inc.. It received FDA 510(k) clearance on 1994-06-10 under 510(k) number K942571. 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 HYPER-INFLATION BAG?

HYPER-INFLATION BAG is a medical device that received FDA 510(k) clearance on 1994-06-10. The listed applicant is Med-Plastics Intl., Inc.. The 510(k) number is K942571.

When did HYPER-INFLATION BAG receive FDA 510(k) clearance?

HYPER-INFLATION BAG received FDA 510(k) clearance on 1994-06-10, under 510(k) number K942571.

Who is the listed applicant for HYPER-INFLATION BAG?

The FDA 510(k) record lists Med-Plastics Intl., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HYPER-INFLATION BAG?

The FDA product code for HYPER-INFLATION BAG is NHK.

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Other records listing Med-Plastics Intl., 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.

K946209DISPODABLE HEAT & MOISTURE EXCHANGER AND FILTER/HMEK942572VOLUME VENTILATORK942569VENTILATOR HOSEK942567MASS SPECTROMETRY MONITORING LINES AND CONNECTORSK942570MAPLESON D CIRCUITK942568ADULT ANESTHESIA BREATHING CIRCUIT

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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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