FDA 510(k)

MONITOR, MODEL HSM-00200; PROBE, MODEL HSP-05065; JACKET, MODEL HSJ-05065

K-Number: K031153 · 2003-11-25

Decision Date2003-11-25

Product CodeDPW

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

MONITOR, MODEL HSM-00200; PROBE, MODEL HSP-05065; JACKET, MODEL HSJ-05065 is the device name listed in this FDA 510(k) record. The listed applicant is Arrow Intl., Inc.. It received FDA 510(k) clearance on 2003-11-25 under 510(k) number K031153. The device is classified under product code DPW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MONITOR, MODEL HSM-00200; PROBE, MODEL HSP-05065; JACKET, MODEL HSJ-05065?

MONITOR, MODEL HSM-00200; PROBE, MODEL HSP-05065; JACKET, MODEL HSJ-05065 is a medical device that received FDA 510(k) clearance on 2003-11-25. The listed applicant is Arrow Intl., Inc.. The 510(k) number is K031153.

When did MONITOR, MODEL HSM-00200; PROBE, MODEL HSP-05065; JACKET, MODEL HSJ-05065 receive FDA 510(k) clearance?

MONITOR, MODEL HSM-00200; PROBE, MODEL HSP-05065; JACKET, MODEL HSJ-05065 received FDA 510(k) clearance on 2003-11-25, under 510(k) number K031153.

Who is the listed applicant for MONITOR, MODEL HSM-00200; PROBE, MODEL HSP-05065; JACKET, MODEL HSJ-05065?

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

What is the FDA product code for MONITOR, MODEL HSM-00200; PROBE, MODEL HSP-05065; JACKET, MODEL HSJ-05065?

The FDA product code for MONITOR, MODEL HSM-00200; PROBE, MODEL HSP-05065; JACKET, MODEL HSJ-05065 is DPW.

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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.