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FDA 510(k)

4010 NON CONDUCTIVE VENTILATOR CIRCUIT W/BACTERIAL

K-Number: K851529 · 1985-04-25

ApplicantSigma Medical, Inc.
Decision Date1985-04-25
Product CodeCAI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

4010 NON CONDUCTIVE VENTILATOR CIRCUIT W/BACTERIAL is the device name listed in this FDA 510(k) record. The listed applicant is Sigma Medical, Inc.. It received FDA 510(k) clearance on 1985-04-25 under 510(k) number K851529. 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 4010 NON CONDUCTIVE VENTILATOR CIRCUIT W/BACTERIAL?

4010 NON CONDUCTIVE VENTILATOR CIRCUIT W/BACTERIAL is a medical device that received FDA 510(k) clearance on 1985-04-25. The listed applicant is Sigma Medical, Inc.. The 510(k) number is K851529.

When did 4010 NON CONDUCTIVE VENTILATOR CIRCUIT W/BACTERIAL receive FDA 510(k) clearance?

4010 NON CONDUCTIVE VENTILATOR CIRCUIT W/BACTERIAL received FDA 510(k) clearance on 1985-04-25, under 510(k) number K851529.

Who is the listed applicant for 4010 NON CONDUCTIVE VENTILATOR CIRCUIT W/BACTERIAL?

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

What is the FDA product code for 4010 NON CONDUCTIVE VENTILATOR CIRCUIT W/BACTERIAL?

The FDA product code for 4010 NON CONDUCTIVE VENTILATOR CIRCUIT W/BACTERIAL is CAI.

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Other records listing Sigma 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.

K853065#6003 NON CONDUCTIVE ANESTHESIA CIR W/ BREATH BAGK8533433015 PEDIATRIC NON-CONDUCTIVE ANESTHESIA CIRCUIT WK8533444000 NON CONDUCTIVE ANESTHESIA VENTILATOR CIRCUITK8533426013 NON CONDUCTIVE ANESTHESIA CIRCUIT W/BREATHBAGK852314#6010 NON-CONDUCTIVE VENTILATOR CIRCUITK852313#3001 PEDIATRIC NON-CONDUCT ANES CIR W/ BREA BAG

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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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