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FDA 510(k)

ARTEC TWIST VALVE

K-Number: K830056 · 1983-03-09

ApplicantArtec Environmental Monitoring Division
Decision Date1983-03-09
Product CodeBTC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ARTEC TWIST VALVE is the device name listed in this FDA 510(k) record. The listed applicant is Artec Environmental Monitoring Division. It received FDA 510(k) clearance on 1983-03-09 under 510(k) number K830056. The device is classified under product code BTC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARTEC TWIST VALVE?

ARTEC TWIST VALVE is a medical device that received FDA 510(k) clearance on 1983-03-09. The listed applicant is Artec Environmental Monitoring Division. The 510(k) number is K830056.

When did ARTEC TWIST VALVE receive FDA 510(k) clearance?

ARTEC TWIST VALVE received FDA 510(k) clearance on 1983-03-09, under 510(k) number K830056.

Who is the listed applicant for ARTEC TWIST VALVE?

The FDA 510(k) record lists Artec Environmental Monitoring Division as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARTEC TWIST VALVE?

The FDA product code for ARTEC TWIST VALVE is BTC.

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Other records listing Artec Environmental Monitoring Division 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.

K900839THE CAROLINA ROCKERK896886ARTEC RESPOND PULMONARY RESUSCITATORK873043MOUTH TO FACE RESUSCITATORK863910RAINCOATK854573ANESTHESIA SHUTOFF VALVE POSITIVE CLOSUREK832512AIRWAY MASKS

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Related Devices (Code: BTC)

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.

K181424PeDIAPedia, LLCK940220REBREATHER BAGSZefon Medical ProductsK932584BREATHING BAGSMerit Medical Systems, Inc.K932496PRECISION MED PRODUCTS, LTD. BREATHING BAGSPrecision Med Products, Ltd.K932581BREATHING BAGSMed-Plastics Intl., Inc.K932191BREATHING BAGSLife Shield Healthcare Products, 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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