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FDA 510(k)

AMBU RUBEN CIRCLE ANESTHESIA SYSTEM

K-Number: K844149 · 1984-11-15

ApplicantAmbu, Inc.
Decision Date1984-11-15
Product CodeCAI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AMBU RUBEN CIRCLE ANESTHESIA SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ambu, Inc.. It received FDA 510(k) clearance on 1984-11-15 under 510(k) number K844149. 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 AMBU RUBEN CIRCLE ANESTHESIA SYSTEM?

AMBU RUBEN CIRCLE ANESTHESIA SYSTEM is a medical device that received FDA 510(k) clearance on 1984-11-15. The listed applicant is Ambu, Inc.. The 510(k) number is K844149.

When did AMBU RUBEN CIRCLE ANESTHESIA SYSTEM receive FDA 510(k) clearance?

AMBU RUBEN CIRCLE ANESTHESIA SYSTEM received FDA 510(k) clearance on 1984-11-15, under 510(k) number K844149.

Who is the listed applicant for AMBU RUBEN CIRCLE ANESTHESIA SYSTEM?

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

What is the FDA product code for AMBU RUBEN CIRCLE ANESTHESIA SYSTEM?

The FDA product code for AMBU RUBEN CIRCLE ANESTHESIA SYSTEM is CAI.

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Other records listing Ambu, Inc. as applicant

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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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