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FDA 510(k)

CIRCUIT, ANES. BREATHING (NON-REBREATHING)

K-Number: K861438 · 1986-05-09

ApplicantVital Signs, Inc.
Decision Date1986-05-09
Product CodeCAI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CIRCUIT, ANES. BREATHING (NON-REBREATHING) is the device name listed in this FDA 510(k) record. The listed applicant is Vital Signs, Inc.. It received FDA 510(k) clearance on 1986-05-09 under 510(k) number K861438. 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 CIRCUIT, ANES. BREATHING (NON-REBREATHING)?

CIRCUIT, ANES. BREATHING (NON-REBREATHING) is a medical device that received FDA 510(k) clearance on 1986-05-09. The listed applicant is Vital Signs, Inc.. The 510(k) number is K861438.

When did CIRCUIT, ANES. BREATHING (NON-REBREATHING) receive FDA 510(k) clearance?

CIRCUIT, ANES. BREATHING (NON-REBREATHING) received FDA 510(k) clearance on 1986-05-09, under 510(k) number K861438.

Who is the listed applicant for CIRCUIT, ANES. BREATHING (NON-REBREATHING)?

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

What is the FDA product code for CIRCUIT, ANES. BREATHING (NON-REBREATHING)?

The FDA product code for CIRCUIT, ANES. BREATHING (NON-REBREATHING) is CAI.

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Other records listing Vital Signs, Inc. as applicant

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K112902ENFLOW IV FLUID WARMERK041309IMASK TMK030985BREAS PV 10I CPAP SYSTEM, MODEL PV 10IK022402DISPOSABLE PRESSURE MANOMETERK021315SURE-LOKK002454BREAS HA50 HUMIDIFIER, MODEL HA50

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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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