Ohio Temperature Simulator
FDA 510(k) K832418 · Airco/Ohio Medical Products
510(k) numberK832418
Submission
- Device name
- Ohio Temperature Simulator
- Applicant
- Airco/Ohio Medical Products
Mchenry, IL, US - Received
- July 22, 1983
- Decision date
- September 12, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FMZ – Incubator, Neonatal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5400
- Specialty
- General Hospital
Other 510(k)s with product code FMZ
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| K260326 | Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)FMZ · Traditional | Datex-Ohmeda, Inc. | 07/28/2026SE |
| K251619 | Babyleo TN500FMZ · Traditional | Drägerwerk AG & Co. KGaA | 02/13/2026SE |
| K251663 | Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)FMZ · Traditional | Datex-Ohmeda, Inc. | 10/22/2025SE |
| K243437 | mOm Essential Incubator (ME1)FMZ · Traditional | Mom Incubators Limited | 08/14/2025SE |
| K213553 | Giraffe Incubator Carestation CS1FMZ · Traditional | Datex Ohmeda, Inc. | 03/02/2022SE |
| K190494 | Infant IncubatorFMZ · Traditional | Ningbo David Medical Device Co., Ltd. | 11/25/2019SE |
| K182859 | Babyleo TN500FMZ · Special | Dragerwerk AG & CO Kgaa | 02/22/2019SE |
| K182977 | Isolette 8000 PlusFMZ · Special | Draeger Medical Systems, Inc. | 11/21/2018SE |
| K172154 | Isolette 8000 plusFMZ · Traditional | Draeger Medical Sytems, Inc. | 04/19/2018SE |
| K162821 | Babyleo TN500FMZ · Traditional | Draegerwerk AG & CO Kgaa | 06/23/2017SE |
More from Draegerwerk AG & CO Kgaa
| 510(k) | Device | Decision |
|---|---|---|
| K833459 | Coaxial Vol. Ventilator CircuitBZO · Traditional | 01/10/1984SE |
| K833452 | Ohio GMS AbsorberBSF · Traditional | 11/29/1983SE |
| K832565 | Ohio 5400 Volume MonitorBZK · Traditional | 09/01/1983SE |
| K832185 | Ohio Model 922 SpirometerBZG · Traditional | 08/12/1983SE |
| K830446 | Oxygen Monitor Ohio 5100CCL · Traditional | 03/24/1983SE |
| K822456 | Ohio V5A Anesthesia VentilatorCBK · Traditional | 09/21/1982SE |
| K813476 | Ohio Volume Incentive SpirometerBWF · Traditional | 12/31/1981SE |
| K812880 | Ohio Non-Reusable Tracheal Tube MajillBTR · Traditional | 11/24/1981SE |
| K812879 | Ohio Non-Reusable Tracheal Tube MurphyBTR · Traditional | 11/24/1981SE |
| K811413 | Dabc Nonconductive Pediat. Anesth. CirCAI · Traditional | 06/02/1981SE |
Questions and answers
When was Ohio Temperature Simulator cleared by the FDA?
Ohio Temperature Simulator (K832418) received a 510(k) decision of Substantially Equivalent on September 12, 1983, 52 days after the submission was received.
What is the product code of K832418?
The FDA product code is FMZ – Incubator, Neonatal, a Class II (moderate risk) device regulated under 21 CFR 880.5400.