FDA 510(k)

CAMINO SINGLE PARAMETER MONITOR, MODEL SPM-1

K-Number: K031086 · 2003-05-14

Decision Date2003-05-14

Product CodeGWM

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

CAMINO SINGLE PARAMETER MONITOR, MODEL SPM-1 is the device name listed in this FDA 510(k) record. The listed applicant is Integra Neurosciences. It received FDA 510(k) clearance on 2003-05-14 under 510(k) number K031086. The device is classified under product code GWM. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAMINO SINGLE PARAMETER MONITOR, MODEL SPM-1?

CAMINO SINGLE PARAMETER MONITOR, MODEL SPM-1 is a medical device that received FDA 510(k) clearance on 2003-05-14. The listed applicant is Integra Neurosciences. The 510(k) number is K031086.

When did CAMINO SINGLE PARAMETER MONITOR, MODEL SPM-1 receive FDA 510(k) clearance?

CAMINO SINGLE PARAMETER MONITOR, MODEL SPM-1 received FDA 510(k) clearance on 2003-05-14, under 510(k) number K031086.

Who is the listed applicant for CAMINO SINGLE PARAMETER MONITOR, MODEL SPM-1?

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

What is the FDA product code for CAMINO SINGLE PARAMETER MONITOR, MODEL SPM-1?

The FDA product code for CAMINO SINGLE PARAMETER MONITOR, MODEL SPM-1 is GWM.

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Related Devices (Code: GWM)

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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.