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FDA 510(k)

SPACELABS MEDICAL EXPANSION MODULE (MODEL 90352)

K-Number: K945429 · 1995-08-15

ApplicantSpacelabs Medical, Inc.
Decision Date1995-08-15
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SPACELABS MEDICAL EXPANSION MODULE (MODEL 90352) 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 1995-08-15 under 510(k) number K945429. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPACELABS MEDICAL EXPANSION MODULE (MODEL 90352)?

SPACELABS MEDICAL EXPANSION MODULE (MODEL 90352) is a medical device that received FDA 510(k) clearance on 1995-08-15. The listed applicant is Spacelabs Medical, Inc.. The 510(k) number is K945429.

When did SPACELABS MEDICAL EXPANSION MODULE (MODEL 90352) receive FDA 510(k) clearance?

SPACELABS MEDICAL EXPANSION MODULE (MODEL 90352) received FDA 510(k) clearance on 1995-08-15, under 510(k) number K945429.

Who is the listed applicant for SPACELABS MEDICAL EXPANSION MODULE (MODEL 90352)?

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 EXPANSION MODULE (MODEL 90352)?

The FDA product code for SPACELABS MEDICAL EXPANSION MODULE (MODEL 90352) is DSI.

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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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Related Devices (Code: DSI)

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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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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