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FDA 510(k)

IP-SET

K-Number: K101685 · 2010-07-01

ApplicantIntegral Process Sas
Decision Date2010-07-01
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

IP-SET is the device name listed in this FDA 510(k) record. The listed applicant is Integral Process Sas. It received FDA 510(k) clearance on 2010-07-01 under 510(k) number K101685. The device is classified under product code DRX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IP-SET?

IP-SET is a medical device that received FDA 510(k) clearance on 2010-07-01. The listed applicant is Integral Process Sas. The 510(k) number is K101685.

When did IP-SET receive FDA 510(k) clearance?

IP-SET received FDA 510(k) clearance on 2010-07-01, under 510(k) number K101685.

Who is the listed applicant for IP-SET?

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

What is the FDA product code for IP-SET?

The FDA product code for IP-SET is DRX.

Other records listing Integral Process Sas as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K162768ECG multi leads and IP-SET trunk cable, Monobloc ECG cable, SpO2 sensors and IBP transducers interface cable, ECG leadwire for INTEGRAL PROCESS trunk cables, ECG leadwire for original truk cables

Related Devices (Code: DRX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K171244PhysiotraceNimbleheart, Inc.K123658BIOMODULE 3-M1Zephyr Technology CorporationK101576CENTERRIDGE DIAGNOSTIC ECG ELECTRODE, CENTERRIDGE MONITORING ECG ELECTRODESTeam Innovations, Inc.K100129AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO XAmbu A/SK093327INTCO TAB ELECTRODEShanghai Intco Electrode Manufacturing Co., Ltd.K10031512 LEAD GLOVEI Needmd, Inc.

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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