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FDA 510(k)

MAUNA LOA ENHANCED HEATED BREATHING CIRCUIT

K-Number: K904538 · 1991-04-24

ApplicantMauna Loa Medical, Inc.
Decision Date1991-04-24
Product CodeCAI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MAUNA LOA ENHANCED HEATED BREATHING CIRCUIT is the device name listed in this FDA 510(k) record. The listed applicant is Mauna Loa Medical, Inc.. It received FDA 510(k) clearance on 1991-04-24 under 510(k) number K904538. 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 MAUNA LOA ENHANCED HEATED BREATHING CIRCUIT?

MAUNA LOA ENHANCED HEATED BREATHING CIRCUIT is a medical device that received FDA 510(k) clearance on 1991-04-24. The listed applicant is Mauna Loa Medical, Inc.. The 510(k) number is K904538.

When did MAUNA LOA ENHANCED HEATED BREATHING CIRCUIT receive FDA 510(k) clearance?

MAUNA LOA ENHANCED HEATED BREATHING CIRCUIT received FDA 510(k) clearance on 1991-04-24, under 510(k) number K904538.

Who is the listed applicant for MAUNA LOA ENHANCED HEATED BREATHING CIRCUIT?

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

What is the FDA product code for MAUNA LOA ENHANCED HEATED BREATHING CIRCUIT?

The FDA product code for MAUNA LOA ENHANCED HEATED BREATHING CIRCUIT is CAI.

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Other records listing Mauna Loa Medical, 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.

K870173LAVABED SYSTEM & CHAMBER, LAVAPAK TEMP. CONTROL

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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