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FDA 510(k)

PRIMA, INC. ADULT ANESTHESIA CIRCUIT

K-Number: K944533 · 1994-11-29

ApplicantPrima, Inc.
Decision Date1994-11-29
Product CodeCAI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PRIMA, INC. ADULT ANESTHESIA 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 1994-11-29 under 510(k) number K944533. The device is classified under product code CAI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRIMA, INC. ADULT ANESTHESIA CIRCUIT?

PRIMA, INC. ADULT ANESTHESIA CIRCUIT is a medical device that received FDA 510(k) clearance on 1994-11-29. The listed applicant is Prima, Inc.. The 510(k) number is K944533.

When did PRIMA, INC. ADULT ANESTHESIA CIRCUIT receive FDA 510(k) clearance?

PRIMA, INC. ADULT ANESTHESIA CIRCUIT received FDA 510(k) clearance on 1994-11-29, under 510(k) number K944533.

Who is the listed applicant for PRIMA, INC. ADULT ANESTHESIA 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, INC. ADULT ANESTHESIA CIRCUIT?

The FDA product code for PRIMA, INC. ADULT ANESTHESIA CIRCUIT is CAI.

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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 VENTILATORSSK952018PRIMA COAXIAL CIRCUITSK952016PRIMA PEDIATRIC GAS SAMPLING CIRCUITSK952012PRIMA CUSTOM ANESTESIA CIRCUIT

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Related Devices (Code: CAI)

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.

K954480CONDENSATE COLLECTION KITNova-VentrxK953787UNICOR, INC. ADULT ANESTHESIA BREATHING CIRCUITUnicor, Inc.K953788UNICOR, INC. GAS SAMPLING LINES & CONNECTORSUnicor, Inc.K952016PRIMA PEDIATRIC GAS SAMPLING CIRCUITSPrima, Inc.K952018PRIMA COAXIAL CIRCUITSPrima, Inc.K952020PRIMA PEDIATRIC ANESTHESIA CIRCUITSPrima, 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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