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FDA 510(k)

PRIMA BREATHING BAGS

K-Number: K952011 · 1995-05-22

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

Device Summary

PRIMA BREATHING BAGS 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 K952011. The device is classified under product code BZO. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRIMA BREATHING BAGS?

PRIMA BREATHING BAGS 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 K952011.

When did PRIMA BREATHING BAGS receive FDA 510(k) clearance?

PRIMA BREATHING BAGS received FDA 510(k) clearance on 1995-05-22, under 510(k) number K952011.

Who is the listed applicant for PRIMA BREATHING BAGS?

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 BREATHING BAGS?

The FDA product code for PRIMA BREATHING BAGS is BZO.

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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.

K952010PRIMA VENTILATOR HOSESK952012PRIMA CUSTOM ANESTESIA CIRCUITK952022PRIMA VOLUMN VENTILATORSSK952016PRIMA PEDIATRIC GAS SAMPLING CIRCUITSK952018PRIMA COAXIAL CIRCUITSK952020PRIMA PEDIATRIC ANESTHESIA CIRCUITS

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Related Devices (Code: BZO)

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.

K953784UNICOR, INC. CORRUGATED TUBINGUnicor, Inc.K953785UNICOR, INC. VENTILATOR HOSESUnicor, Inc.K952010PRIMA VENTILATOR HOSESPrima, Inc.K952022PRIMA VOLUMN VENTILATORSSPrima, Inc.K952012PRIMA CUSTOM ANESTESIA CIRCUITPrima, Inc.K945740INFANT FLOW SYSTEMHamilton Medical, 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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