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FDA 510(k)

PRIMA HYUPERINFLATION SYSTEM

K-Number: K952021 · 1995-05-22

ApplicantPrima, Inc.
Decision Date1995-05-22
Product CodeBZR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PRIMA HYUPERINFLATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Prima, Inc.. It received FDA 510(k) clearance on 1995-05-22 under 510(k) number K952021. 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 PRIMA HYUPERINFLATION SYSTEM?

PRIMA HYUPERINFLATION SYSTEM is a medical device that received FDA 510(k) clearance on 1995-05-22. The listed applicant is Prima, Inc.. The 510(k) number is K952021.

When did PRIMA HYUPERINFLATION SYSTEM receive FDA 510(k) clearance?

PRIMA HYUPERINFLATION SYSTEM received FDA 510(k) clearance on 1995-05-22, under 510(k) number K952021.

Who is the listed applicant for PRIMA HYUPERINFLATION SYSTEM?

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

What is the FDA product code for PRIMA HYUPERINFLATION SYSTEM?

The FDA product code for PRIMA HYUPERINFLATION SYSTEM is BZR.

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Other records listing Prima, 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.

K952011PRIMA BREATHING BAGSK952010PRIMA VENTILATOR HOSESK952022PRIMA VOLUMN VENTILATORSSK952016PRIMA PEDIATRIC GAS SAMPLING CIRCUITSK952018PRIMA COAXIAL CIRCUITSK952012PRIMA CUSTOM ANESTESIA CIRCUIT

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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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