Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

GIRAFFE AND PANDA WARMERS

K-Number: K123309 · 2013-02-05

ApplicantOhmeda Medical
Decision Date2013-02-05
Product CodeFMT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

GIRAFFE AND PANDA WARMERS is the device name listed in this FDA 510(k) record. The listed applicant is Ohmeda Medical. It received FDA 510(k) clearance on 2013-02-05 under 510(k) number K123309. 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 WARMERS?

GIRAFFE AND PANDA WARMERS is a medical device that received FDA 510(k) clearance on 2013-02-05. The listed applicant is Ohmeda Medical. The 510(k) number is K123309.

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

GIRAFFE AND PANDA WARMERS received FDA 510(k) clearance on 2013-02-05, under 510(k) number K123309.

Who is the listed applicant for GIRAFFE AND PANDA WARMERS?

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 WARMERS?

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

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

K101788GIRAFFE OMNIBEDK101778GIRAFFE INCUBATORK090697MODIFICATION TO: GIRAFFE AND PANDA WARMERK072157MODIFICATION TO GIRAFFE AND PANDA WARMERS (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY)K070377GIRAFFE AND PANDA WARMERK070210GIRAFFE AND PANDA T- PIECE RESUSCITATION SYSTEM

View all 119 devices →

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.

↑