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FDA 510(k)

VENTURE II MONITORING SYSTEM

K-Number: K830321 · 1983-06-03

ApplicantRae Medical Corp.
Decision Date1983-06-03
Product CodeDSF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VENTURE II MONITORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Rae Medical Corp.. It received FDA 510(k) clearance on 1983-06-03 under 510(k) number K830321. The device is classified under product code DSF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VENTURE II MONITORING SYSTEM?

VENTURE II MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 1983-06-03. The listed applicant is Rae Medical Corp.. The 510(k) number is K830321.

When did VENTURE II MONITORING SYSTEM receive FDA 510(k) clearance?

VENTURE II MONITORING SYSTEM received FDA 510(k) clearance on 1983-06-03, under 510(k) number K830321.

Who is the listed applicant for VENTURE II MONITORING SYSTEM?

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

What is the FDA product code for VENTURE II MONITORING SYSTEM?

The FDA product code for VENTURE II MONITORING SYSTEM is DSF.

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.

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Other records listing Rae Medical Corp. 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.

K781256CATHODE RAY TUBE MED. DISPLAYK781255DIGITAL PANEL METER

Related Devices (Code: DSF)

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.

K910871EDENTEC DIGITAL CHARTER MODEL 3710Edentec Corp.K912929DASH IVAstro-Med, Inc.K905856MODEL 556 MONITORGe Medical Systems Information TechnologiesK902586GRI LASERGRAPH(TM) ECG PAPERGri Medical Products, Inc.K902230COLORADO COLOR IMAGING RECORDERHoneywell, Inc.K901385GABRIEL MEDICAL CLS THERMAL RECORDERGabriel Medical, 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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