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FDA 510(k)

LULLABY TM WARMER

K-Number: K121625 · 2012-09-14

ApplicantWipro GE Healthcare Private, Ltd.
Decision Date2012-09-14
Product CodeFMT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

LULLABY TM WARMER 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 2012-09-14 under 510(k) number K121625. The device is classified under product code FMT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LULLABY TM WARMER?

LULLABY TM WARMER is a medical device that received FDA 510(k) clearance on 2012-09-14. The listed applicant is Wipro GE Healthcare Private, Ltd.. The 510(k) number is K121625.

When did LULLABY TM WARMER receive FDA 510(k) clearance?

LULLABY TM WARMER received FDA 510(k) clearance on 2012-09-14, under 510(k) number K121625.

Who is the listed applicant for LULLABY TM WARMER?

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 LULLABY TM WARMER?

The FDA product code for LULLABY TM WARMER is FMT.

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

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Related Devices (Code: FMT)

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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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