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FDA 510(k)

SPECTRUM PATIENT MONITOR, MODEL 0998-00-0500-XXXXX

K-Number: K031849 · 2003-09-09

ApplicantDatascope Corp.
Decision Date2003-09-09
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SPECTRUM PATIENT MONITOR, MODEL 0998-00-0500-XXXXX is the device name listed in this FDA 510(k) record. The listed applicant is Datascope Corp.. It received FDA 510(k) clearance on 2003-09-09 under 510(k) number K031849. 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 SPECTRUM PATIENT MONITOR, MODEL 0998-00-0500-XXXXX?

SPECTRUM PATIENT MONITOR, MODEL 0998-00-0500-XXXXX is a medical device that received FDA 510(k) clearance on 2003-09-09. The listed applicant is Datascope Corp.. The 510(k) number is K031849.

When did SPECTRUM PATIENT MONITOR, MODEL 0998-00-0500-XXXXX receive FDA 510(k) clearance?

SPECTRUM PATIENT MONITOR, MODEL 0998-00-0500-XXXXX received FDA 510(k) clearance on 2003-09-09, under 510(k) number K031849.

Who is the listed applicant for SPECTRUM PATIENT MONITOR, MODEL 0998-00-0500-XXXXX?

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

What is the FDA product code for SPECTRUM PATIENT MONITOR, MODEL 0998-00-0500-XXXXX?

The FDA product code for SPECTRUM PATIENT MONITOR, MODEL 0998-00-0500-XXXXX is MHX.

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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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