FDA 510(k)

PRIMA CUSTOM ANESTESIA CIRCUIT

K-Number: K952012 · 1995-05-22

Decision Date1995-05-22

Product CodeBZO

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

PRIMA CUSTOM ANESTESIA CIRCUIT 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 K952012. 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 CUSTOM ANESTESIA CIRCUIT?

PRIMA CUSTOM ANESTESIA CIRCUIT 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 K952012.

When did PRIMA CUSTOM ANESTESIA CIRCUIT receive FDA 510(k) clearance?

PRIMA CUSTOM ANESTESIA CIRCUIT received FDA 510(k) clearance on 1995-05-22, under 510(k) number K952012.

Who is the listed applicant for PRIMA CUSTOM ANESTESIA CIRCUIT?

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 CUSTOM ANESTESIA CIRCUIT?

The FDA product code for PRIMA CUSTOM ANESTESIA CIRCUIT is BZO.

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Other records listing Prima, Inc. as applicant

K952011PRIMA BREATHING BAGS K952010PRIMA VENTILATOR HOSES K952022PRIMA VOLUMN VENTILATORSS K952016PRIMA PEDIATRIC GAS SAMPLING CIRCUITS K952018PRIMA COAXIAL CIRCUITS K952020PRIMA PEDIATRIC ANESTHESIA CIRCUITS

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Related Devices (Code: BZO)

K953784UNICOR, INC. CORRUGATED TUBINGUnicor, Inc.K953785UNICOR, INC. VENTILATOR HOSESUnicor, Inc.K952011PRIMA BREATHING BAGSPrima, Inc.K952022PRIMA VOLUMN VENTILATORSSPrima, Inc.K952010PRIMA VENTILATOR HOSESPrima, 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.