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FDA 510(k)

#3002 PEDIATRIC NON-CONDUCT ANES CIR W/ BREA BAG

K-Number: K852311 · 1985-07-15

ApplicantSigma Medical, Inc.
Decision Date1985-07-15
Product CodeCAI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

#3002 PEDIATRIC NON-CONDUCT ANES CIR W/ BREA BAG 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 1985-07-15 under 510(k) number K852311. 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 #3002 PEDIATRIC NON-CONDUCT ANES CIR W/ BREA BAG?

#3002 PEDIATRIC NON-CONDUCT ANES CIR W/ BREA BAG is a medical device that received FDA 510(k) clearance on 1985-07-15. The listed applicant is Sigma Medical, Inc.. The 510(k) number is K852311.

When did #3002 PEDIATRIC NON-CONDUCT ANES CIR W/ BREA BAG receive FDA 510(k) clearance?

#3002 PEDIATRIC NON-CONDUCT ANES CIR W/ BREA BAG received FDA 510(k) clearance on 1985-07-15, under 510(k) number K852311.

Who is the listed applicant for #3002 PEDIATRIC NON-CONDUCT ANES CIR W/ BREA BAG?

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 #3002 PEDIATRIC NON-CONDUCT ANES CIR W/ BREA BAG?

The FDA product code for #3002 PEDIATRIC NON-CONDUCT ANES CIR W/ BREA BAG 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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