MODIFICATION TO GIRAFFE AND PANDA WARMERS (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY)— 510(k) K072157

Name: FDA 510(k) clearance K072157
Creator: U.S. Food and Drug Administration
Published: 2007-08-27

Substantially Equivalent

Ohmeda Medical

FDA 510(k) clearance K072157 for MODIFICATION TO GIRAFFE AND PANDA WARMERS (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY), Substantially Equivalent on 2007-08-27. Applicant: Ohmeda Medical. Device class: 2.

Clearance details

Applicant: Ohmeda Medical
Product code: Code FMT
Device class: Class 2
Regulation: 21 CFR 880.5130
Advisory panel: General Hospital
Date received: 2007-08-03
Decision date: 2007-08-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Laurel, MD, US

Download summary PDF View on FDA.gov ↗

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K200319 — HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface Cable2020-04-02

More clearances from Ohmeda Medical

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K123309 — GIRAFFE AND PANDA WARMERS2013-02-05
K101778 — GIRAFFE INCUBATOR2010-07-21
K101788 — GIRAFFE OMNIBED2010-07-21
K090697 — MODIFICATION TO: GIRAFFE AND PANDA WARMER2009-04-16
K070377 — GIRAFFE AND PANDA WARMER2007-07-11

Adverse events under product code FMT

product code FMT

Death: 4
Malfunction: 3,074
Total: 3,078

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K072157

K-number listed on FDA's recall record

Z-1507-2017 — Giraffe Bedded Warmer, Panda Warmer Modification to Giraffe and Panda Warmers (Giraffe and Panda Uninterruptible Power Supply) - Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonate's transition to the external environment or to provide a controlled open environment. An optional integrated SpO2 monitoring feature may be used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SP02 sensor). An optional integrated resuscitation system may be used to provide the basic equipment required for pulmonary resuscitation of infants. Pulmonary resuscitation includes practices necessary to establish a clear airway and provide oxygen or air/oxygen mixtures and/or manual ventilation to the infant.Class II·Terminated·Ohmeda Medical·20161118

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K072157.

Data sourced from openFDA. This site is unofficial and independent of the FDA.