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FDA 510(k)

2010 PLUS HOLTER FOR WINDOWS

K-Number: K010949 · 2001-09-28

ApplicantAgilent Technologies
Decision Date2001-09-28
Product CodeMLO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

2010 PLUS HOLTER FOR WINDOWS is the device name listed in this FDA 510(k) record. The listed applicant is Agilent Technologies. It received FDA 510(k) clearance on 2001-09-28 under 510(k) number K010949. The device is classified under product code MLO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 2010 PLUS HOLTER FOR WINDOWS?

2010 PLUS HOLTER FOR WINDOWS is a medical device that received FDA 510(k) clearance on 2001-09-28. The listed applicant is Agilent Technologies. The 510(k) number is K010949.

When did 2010 PLUS HOLTER FOR WINDOWS receive FDA 510(k) clearance?

2010 PLUS HOLTER FOR WINDOWS received FDA 510(k) clearance on 2001-09-28, under 510(k) number K010949.

Who is the listed applicant for 2010 PLUS HOLTER FOR WINDOWS?

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

What is the FDA product code for 2010 PLUS HOLTER FOR WINDOWS?

The FDA product code for 2010 PLUS HOLTER FOR WINDOWS is MLO.

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Other records listing Agilent Technologies 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.

K0039402010 PLUS HOLTER FOR WINDOWSK0037632010 PLUS HOLTER FOR WINDOWSK001308MODIFICATION TO ZYMED TELEMETRY SYSTEM, MODEL EASIVIEWK990093ZYMED TELEMETRY SYSTEM: MODEL EASIVIEWK980186ZYMED TELEMETRY SYSTEMK942781DIGITAL HOLTER RECORDER

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Related Devices (Code: MLO)

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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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