Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

6013 NON CONDUCTIVE ANESTHESIA CIRCUIT W/BREATHBAG

K-Number: K853342 · 1985-08-29

ApplicantSigma Medical, Inc.
Decision Date1985-08-29
Product CodeCAI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

6013 NON CONDUCTIVE ANESTHESIA CIRCUIT W/BREATHBAG 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 1985-08-29 under 510(k) number K853342. 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 6013 NON CONDUCTIVE ANESTHESIA CIRCUIT W/BREATHBAG?

6013 NON CONDUCTIVE ANESTHESIA CIRCUIT W/BREATHBAG is a medical device that received FDA 510(k) clearance on 1985-08-29. The listed applicant is Sigma Medical, Inc.. The 510(k) number is K853342.

When did 6013 NON CONDUCTIVE ANESTHESIA CIRCUIT W/BREATHBAG receive FDA 510(k) clearance?

6013 NON CONDUCTIVE ANESTHESIA CIRCUIT W/BREATHBAG received FDA 510(k) clearance on 1985-08-29, under 510(k) number K853342.

Who is the listed applicant for 6013 NON CONDUCTIVE ANESTHESIA CIRCUIT W/BREATHBAG?

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 6013 NON CONDUCTIVE ANESTHESIA CIRCUIT W/BREATHBAG?

The FDA product code for 6013 NON CONDUCTIVE ANESTHESIA CIRCUIT W/BREATHBAG is CAI.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 CIRCUITK852314#6010 NON-CONDUCTIVE VENTILATOR CIRCUITK852313#3001 PEDIATRIC NON-CONDUCT ANES CIR W/ BREA BAGK852316#3011 PEDIATRIC NON-CONDUCT ANES CIR W/ BREA BAG

View all 13 devices →

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.

↑