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FDA 510(k)

Babyroo TN300

K-Number: K243606 · 2025-01-17

ApplicantDraeger Medical Systems, Inc.
Decision Date2025-01-17
Product CodeFMT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Babyroo TN300 is the device name listed in this FDA 510(k) record. The listed applicant is Draeger Medical Systems, Inc.. It received FDA 510(k) clearance on 2025-01-17 under 510(k) number K243606. 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 Babyroo TN300?

Babyroo TN300 is a medical device that received FDA 510(k) clearance on 2025-01-17. The listed applicant is Draeger Medical Systems, Inc.. The 510(k) number is K243606.

When did Babyroo TN300 receive FDA 510(k) clearance?

Babyroo TN300 received FDA 510(k) clearance on 2025-01-17, under 510(k) number K243606.

Who is the listed applicant for Babyroo TN300?

The FDA 510(k) record lists Draeger Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Babyroo TN300?

The FDA product code for Babyroo TN300 is FMT.

Other records listing Draeger Medical Systems, Inc. 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.

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Related Devices (Code: FMT)

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.

K230278Babyroo TN300Draeger Medical Systems, Inc.K213551Giraffe Omnibed Carestation CS1Datex Ohmeda, Inc.K201628Panda iRes Warmer, Giraffe WarmerGE HealthcareK200319HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface CableDeroyal Industries, Inc.K191425Hydro-Temp Neonatal Skin Temperature Probe CoverDeroyal Industries, Inc.K173516NuBorne Infant WarmerInternational Biomedical

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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