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FDA 510(k)

HYPERINFLATION SYSTEM

K-Number: K932557 · 1993-07-22

ApplicantLife Shield Healthcare Products, Inc.
Decision Date1993-07-22
Product CodeBZR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

HYPERINFLATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Life Shield Healthcare Products, Inc.. It received FDA 510(k) clearance on 1993-07-22 under 510(k) number K932557. The device is classified under product code BZR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYPERINFLATION SYSTEM?

HYPERINFLATION SYSTEM is a medical device that received FDA 510(k) clearance on 1993-07-22. The listed applicant is Life Shield Healthcare Products, Inc.. The 510(k) number is K932557.

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

HYPERINFLATION SYSTEM received FDA 510(k) clearance on 1993-07-22, under 510(k) number K932557.

Who is the listed applicant for HYPERINFLATION SYSTEM?

The FDA 510(k) record lists Life Shield Healthcare Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HYPERINFLATION SYSTEM?

The FDA product code for HYPERINFLATION SYSTEM is BZR.

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Other records listing Life Shield Healthcare Products, 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.

K932562GAS SAMPLING LINES AND CONNECTORSK932560VOLUME VENTILATORSK932558ADULT ANESTHESIA BREATHING CIRCUITK932561GUEDEL AIRWAYSK932559MAPLESON D CIRCUITSK932563VENTILATOR HOSES

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Related Devices (Code: BZR)

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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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