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FDA 510(k)

DISPOSABLE ADULT VO. VENTILATOR CIRCUIT

K-Number: K823271 · 1982-12-22

ApplicantIntec Medical, Inc.
Decision Date1982-12-22
Product CodeBZO
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE ADULT VO. VENTILATOR CIRCUIT is the device name listed in this FDA 510(k) record. The listed applicant is Intec Medical, Inc.. It received FDA 510(k) clearance on 1982-12-22 under 510(k) number K823271. The device is classified under product code BZO. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISPOSABLE ADULT VO. VENTILATOR CIRCUIT?

DISPOSABLE ADULT VO. VENTILATOR CIRCUIT is a medical device that received FDA 510(k) clearance on 1982-12-22. The listed applicant is Intec Medical, Inc.. The 510(k) number is K823271.

When did DISPOSABLE ADULT VO. VENTILATOR CIRCUIT receive FDA 510(k) clearance?

DISPOSABLE ADULT VO. VENTILATOR CIRCUIT received FDA 510(k) clearance on 1982-12-22, under 510(k) number K823271.

Who is the listed applicant for DISPOSABLE ADULT VO. VENTILATOR CIRCUIT?

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

What is the FDA product code for DISPOSABLE ADULT VO. VENTILATOR CIRCUIT?

The FDA product code for DISPOSABLE ADULT VO. VENTILATOR CIRCUIT is BZO.

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Other records listing Intec Medical, Inc. as applicant

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K911840INTERFLO MEDICAL MODEL PA3-H CCO/PAC CATHETERK903217TAPERED TIP THE GUIDER CORONARY GUIDING CATHETERK903216THE GUIDER CORONARY GUIDING CATHETERK900710INTERFLO MEDICAL MODEL F-1 THERMODILUTION CATHETERK903840GIANT LUMEN SAFETIP SERIES: ENDOMYOCARDIAL BIOPSYK903906PERCUTANEOUS CATHETER INTRODUCER KIT

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Related Devices (Code: BZO)

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.

K953784UNICOR, INC. CORRUGATED TUBINGUnicor, Inc.K953785UNICOR, INC. VENTILATOR HOSESUnicor, Inc.K952011PRIMA BREATHING BAGSPrima, Inc.K952022PRIMA VOLUMN VENTILATORSSPrima, Inc.K952010PRIMA VENTILATOR HOSESPrima, Inc.K952012PRIMA CUSTOM ANESTESIA CIRCUITPrima, 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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