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FDA 510(k)

SPACELABS MULTI-PARAMETER MODULE

K-Number: K103142 · 2011-03-03

ApplicantSpacelabs Healthcare, Inc.
Decision Date2011-03-03
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SPACELABS MULTI-PARAMETER MODULE is the device name listed in this FDA 510(k) record. The listed applicant is Spacelabs Healthcare, Inc.. It received FDA 510(k) clearance on 2011-03-03 under 510(k) number K103142. 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 MULTI-PARAMETER MODULE?

SPACELABS MULTI-PARAMETER MODULE is a medical device that received FDA 510(k) clearance on 2011-03-03. The listed applicant is Spacelabs Healthcare, Inc.. The 510(k) number is K103142.

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

SPACELABS MULTI-PARAMETER MODULE received FDA 510(k) clearance on 2011-03-03, under 510(k) number K103142.

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

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

What is the FDA product code for SPACELABS MULTI-PARAMETER MODULE?

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

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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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