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FDA 510(k)

GIRAFFE AND PANDA WARMER

K-Number: K070377 · 2007-07-11

ApplicantOhmeda Medical
Decision Date2007-07-11
Product CodeFMT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

GIRAFFE AND PANDA WARMER is the device name listed in this FDA 510(k) record. The listed applicant is Ohmeda Medical. It received FDA 510(k) clearance on 2007-07-11 under 510(k) number K070377. 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 GIRAFFE AND PANDA WARMER?

GIRAFFE AND PANDA WARMER is a medical device that received FDA 510(k) clearance on 2007-07-11. The listed applicant is Ohmeda Medical. The 510(k) number is K070377.

When did GIRAFFE AND PANDA WARMER receive FDA 510(k) clearance?

GIRAFFE AND PANDA WARMER received FDA 510(k) clearance on 2007-07-11, under 510(k) number K070377.

Who is the listed applicant for GIRAFFE AND PANDA WARMER?

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

What is the FDA product code for GIRAFFE AND PANDA WARMER?

The FDA product code for GIRAFFE AND PANDA WARMER is FMT.

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Other records listing Ohmeda Medical 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.

K123309GIRAFFE AND PANDA WARMERSK101778GIRAFFE INCUBATORK101788GIRAFFE OMNIBEDK090697MODIFICATION TO: GIRAFFE AND PANDA WARMERK072157MODIFICATION TO GIRAFFE AND PANDA WARMERS (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY)K070247GIRAFFE AND PANDA BAG AND MASK RESUSCITATION SYSTEM

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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.

K243606Babyroo TN300Draeger Medical Systems, Inc.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.

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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