Question 1

Who is the manufacturer of AGILENT COMPONENT MONITORING SYSTEM, AGILENT V24/26, AGILENT BIS MODULE, MODEL M1175A/76A/77A,REV.L,M1205A,REV.L,M1034A?

Accepted Answer

Agilent Technologies Deutschland GmbH filed the 510(k) submission for AGILENT COMPONENT MONITORING SYSTEM, AGILENT V24/26, AGILENT BIS MODULE, MODEL M1175A/76A/77A,REV.L,M1205A,REV.L,M1034A (K003038).

Question 2

What is the FDA product code for AGILENT COMPONENT MONITORING SYSTEM, AGILENT V24/26, AGILENT BIS MODULE, MODEL M1175A/76A/77A,REV.L,M1205A,REV.L,M1034A?

Accepted Answer

OLW. It is classified under 21 CFR 882.1400 as a Class 2 device in the Neurology panel.

Question 3

When was AGILENT COMPONENT MONITORING SYSTEM, AGILENT V24/26, AGILENT BIS MODULE, MODEL M1175A/76A/77A,REV.L,M1205A,REV.L,M1034A cleared by the FDA?

Accepted Answer

Dec 15, 2000 (decision: SESE).

Question 4

What is the regulatory pathway for AGILENT COMPONENT MONITORING SYSTEM, AGILENT V24/26, AGILENT BIS MODULE, MODEL M1175A/76A/77A,REV.L,M1205A,REV.L,M1034A?

Accepted Answer

510(k) clearance (submission type: Traditional).

Question 5

Who can help prepare an FDA 510(k) submission like AGILENT COMPONENT MONITORING SYSTEM, AGILENT V24/26, AGILENT BIS MODULE, MODEL M1175A/76A/77A,REV.L,M1205A,REV.L,M1034A?

Accepted Answer

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Record ID	K003038
Device Name	AGILENT COMPONENT MONITORING SYSTEM, AGILENT V24/26, AGILENT BIS MODULE, MODEL M1175A/76A/77A,REV.L,M1205A,REV.L,M1034A
Applicant	Agilent Technologies Deutschland GmbH
Product Code	OLW · Neurology
Decision Date	Dec 15, 2000
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.1400
Device Class	Class 2

AGILENT COMPONENT MONITORING SYSTEM, AGILENT V24/26, AGILENT BIS MODULE, MODEL M1175A/76A/77A,REV.L,M1205A,REV.L,M1034A

Device Facts

Regulatory Classification

Identification