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FDA 510(k)

XYZ SYSTEM

K-Number: K983550 · 1999-01-07

ApplicantBio-Monitoring International Corp.
Decision Date1999-01-07
Product CodeHCC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

XYZ SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Monitoring International Corp.. It received FDA 510(k) clearance on 1999-01-07 under 510(k) number K983550. The device is classified under product code HCC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XYZ SYSTEM?

XYZ SYSTEM is a medical device that received FDA 510(k) clearance on 1999-01-07. The listed applicant is Bio-Monitoring International Corp.. The 510(k) number is K983550.

When did XYZ SYSTEM receive FDA 510(k) clearance?

XYZ SYSTEM received FDA 510(k) clearance on 1999-01-07, under 510(k) number K983550.

Who is the listed applicant for XYZ SYSTEM?

The FDA 510(k) record lists Bio-Monitoring International Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for XYZ SYSTEM?

The FDA product code for XYZ SYSTEM is HCC.

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Related Devices (Code: HCC)

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.

K233580A Breathing System (ABS)Deepwell Dtx, Inc.K222101PrismGraymatters Health , Ltd.K180173FreespiraPalo Alto Health Sciences, Inc.K163448GrindCare SystemSunstar Suisse S.A.K131586CANARY BREATHING SYSTEMPalo Alto Health Sciences, Inc.K122879EEGER4 MODEL 4.3Eeg Software, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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