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FDA 510(k)

SPACELABS MEDICAL INTEGRATED MULTI-PARAMETER MODULE

K-Number: K952912 · 1997-04-02

ApplicantSpacelabs Medical, Inc.
Decision Date1997-04-02
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SPACELABS MEDICAL INTEGRATED MULTI-PARAMETER MODULE 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 1997-04-02 under 510(k) number K952912. 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 INTEGRATED MULTI-PARAMETER MODULE?

SPACELABS MEDICAL INTEGRATED MULTI-PARAMETER MODULE is a medical device that received FDA 510(k) clearance on 1997-04-02. The listed applicant is Spacelabs Medical, Inc.. The 510(k) number is K952912.

When did SPACELABS MEDICAL INTEGRATED MULTI-PARAMETER MODULE receive FDA 510(k) clearance?

SPACELABS MEDICAL INTEGRATED MULTI-PARAMETER MODULE received FDA 510(k) clearance on 1997-04-02, under 510(k) number K952912.

Who is the listed applicant for SPACELABS MEDICAL INTEGRATED MULTI-PARAMETER MODULE?

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 INTEGRATED MULTI-PARAMETER MODULE?

The FDA product code for SPACELABS MEDICAL INTEGRATED MULTI-PARAMETER MODULE is DSI.

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Other records listing Spacelabs Medical, Inc. as applicant

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Related Devices (Code: DSI)

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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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