Ohio GC Incubator
FDA 510(k) K802640 · Ohio Medical Products
510(k) numberK802640
Submission
- Device name
- Ohio GC Incubator
- Applicant
- Ohio Medical Products
Mchenry, IL, US - Received
- October 23, 1980
- Decision date
- November 12, 1980
- 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
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K841733 | Ohio Waste Gas Scavenging ReservoirCBN · Traditional | 07/11/1984SE |
| K842003 | Ohio Waste Gas Scavenging InterfaceCBN · Traditional | 05/23/1984SE |
| K840356 | Ohio Unitrol II Anesthesia Gas MachineBSZ · Traditional | 04/20/1984SE |
| K841274 | Bag-To-Ventilator Selector ValveBSZ · Traditional | 04/13/1984SE |
| K840967 | Ohio Heat Reflecting PatchFMI · Traditional | 03/23/1984SE |
| K840858 | Ohio 3300 Infant Warmer SystemFMT · Traditional | 03/23/1984SE |
| K840857 | Ohio 3000 Infant Warmer SystemFMT · Traditional | 03/23/1984SE |
| K840453 | Medishield PVM RespirometerBZK · Traditional | 03/02/1984SE |
| K840452 | Premium Dabm Dispos. Anes. Breath MaskBSJ · Traditional | 02/17/1984SE |
| K833335 | Modulus II Anesthesia Gas MachineBSZ · Traditional | 11/14/1983SE |
Questions and answers
When was Ohio GC Incubator cleared by the FDA?
Ohio GC Incubator (K802640) received a 510(k) decision of Substantially Equivalent on November 12, 1980, 20 days after the submission was received.
What is the product code of K802640?
The FDA product code is FMZ – Incubator, Neonatal, a Class II (moderate risk) device regulated under 21 CFR 880.5400.