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FDA 510(k)

SPACELABS MEDICAL ULTRAVIEW DIGITAL TELEMTRY SYSTEM

K-Number: K983996 · 1999-06-03

ApplicantSpacelabs Medical, Inc.
Decision Date1999-06-03
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SPACELABS MEDICAL ULTRAVIEW DIGITAL TELEMTRY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Spacelabs Medical, Inc.. It received FDA 510(k) clearance on 1999-06-03 under 510(k) number K983996. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPACELABS MEDICAL ULTRAVIEW DIGITAL TELEMTRY SYSTEM?

SPACELABS MEDICAL ULTRAVIEW DIGITAL TELEMTRY SYSTEM is a medical device that received FDA 510(k) clearance on 1999-06-03. The listed applicant is Spacelabs Medical, Inc.. The 510(k) number is K983996.

When did SPACELABS MEDICAL ULTRAVIEW DIGITAL TELEMTRY SYSTEM receive FDA 510(k) clearance?

SPACELABS MEDICAL ULTRAVIEW DIGITAL TELEMTRY SYSTEM received FDA 510(k) clearance on 1999-06-03, under 510(k) number K983996.

Who is the listed applicant for SPACELABS MEDICAL ULTRAVIEW DIGITAL TELEMTRY SYSTEM?

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

What is the FDA product code for SPACELABS MEDICAL ULTRAVIEW DIGITAL TELEMTRY SYSTEM?

The FDA product code for SPACELABS MEDICAL ULTRAVIEW DIGITAL TELEMTRY SYSTEM is MHX.

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Other records listing Spacelabs 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.

K120616SPACELABS HEALTHCARE QUBE COMPACT MONITOR (91390K112962SPACELABS HEALTHCARE XPREZZON BESIDE MONITOR(9913930)K102422SPACELABS MEDICAL PATIENT MONITORSK093501ELANCE VITAL SIGNS MONITOR AND ELANCE CENTRAL STATIONK082045MODIFICATION TO MCARE 300 VITAL SIGNS MONITOR, MODEL 91220K063490SPACELABS MEDICAL FULL DISCLOSURE SYSTEM, MODEL 91810

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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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