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FDA 510(k)

MINI TELEMETRY SYSTEM

K-Number: K110556 · 2011-07-19

ApplicantWipro GE Healthcare Private, Ltd.
Decision Date2011-07-19
Product CodeHGM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MINI TELEMETRY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Wipro GE Healthcare Private, Ltd.. It received FDA 510(k) clearance on 2011-07-19 under 510(k) number K110556. The device is classified under product code HGM. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MINI TELEMETRY SYSTEM?

MINI TELEMETRY SYSTEM is a medical device that received FDA 510(k) clearance on 2011-07-19. The listed applicant is Wipro GE Healthcare Private, Ltd.. The 510(k) number is K110556.

When did MINI TELEMETRY SYSTEM receive FDA 510(k) clearance?

MINI TELEMETRY SYSTEM received FDA 510(k) clearance on 2011-07-19, under 510(k) number K110556.

Who is the listed applicant for MINI TELEMETRY SYSTEM?

The FDA 510(k) record lists Wipro GE Healthcare Private, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MINI TELEMETRY SYSTEM?

The FDA product code for MINI TELEMETRY SYSTEM is HGM.

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Other records listing Wipro GE Healthcare Private, Ltd. as applicant

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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.

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