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FDA 510(k)

AMBU PAEDI ANAESTHESIA SYSTEM

K-Number: K792499 · 1979-12-19

ApplicantNarco Air-Shields
Decision Date1979-12-19
Product CodeCAI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AMBU PAEDI ANAESTHESIA SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Narco Air-Shields. It received FDA 510(k) clearance on 1979-12-19 under 510(k) number K792499. 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 PAEDI ANAESTHESIA SYSTEM?

AMBU PAEDI ANAESTHESIA SYSTEM is a medical device that received FDA 510(k) clearance on 1979-12-19. The listed applicant is Narco Air-Shields. The 510(k) number is K792499.

When did AMBU PAEDI ANAESTHESIA SYSTEM receive FDA 510(k) clearance?

AMBU PAEDI ANAESTHESIA SYSTEM received FDA 510(k) clearance on 1979-12-19, under 510(k) number K792499.

Who is the listed applicant for AMBU PAEDI ANAESTHESIA SYSTEM?

The FDA 510(k) record lists Narco Air-Shields as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMBU PAEDI ANAESTHESIA SYSTEM?

The FDA product code for AMBU PAEDI ANAESTHESIA SYSTEM is CAI.

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Other records listing Narco Air-Shields 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.

K820114SYSTEM V.HEART RATE/RESPIR. RATE MONIT.K810953MODEL 533 PHOTOTHERAPY UNITK810474PROBE COVERK802800NARCO AIR-SHEILDS SYS. 100 MONITOR SYSK802126ISOLETTE INCUBATOR C-100K792592AMBU UNIVERSAL SUCTION PUMP

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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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