Neocare Baby-Controlled Incubator
FDA 510(k) K813238 · Vickers America Medical Corp.
510(k) numberK813238
Submission
- Device name
- Neocare Baby-Controlled Incubator
- Applicant
- Vickers America Medical Corp.
Mchenry, IL, US - Received
- November 17, 1981
- Decision date
- January 22, 1982
- 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 |
|---|---|---|
| K840823 | Treonic C30LDR · Traditional | 03/23/1984SE |
| K831838 | Laboratory Data MGMT System SDMSJQP · Traditional | 01/24/1984SE |
| K830748 | ResuscitaireFMT · Traditional | 06/22/1983SE |
| K830936 | Treonic IP5FRN · Traditional | 04/12/1983SE |
| K813239 | Oxygenaire Nuring IncubatorFMZ · Traditional | 01/28/1982SE |
| K811865 | Vma Pediatric Apnea MattressBZQ · Traditional | 07/31/1981SE |
| K810792 | Neocare Temperature MonitorFMZ · Traditional | 04/29/1981SE |
| K810571 | Neocare Oxygen MonitorCCL · Traditional | 03/11/1981SE |
| K810067 | 140 Neocare Air Controlled IncubatorFMZ · Traditional | 03/11/1981SE |
| K802251 | SP 120 SophisticateJQP · Traditional | 10/23/1980SE |
Questions and answers
When was Neocare Baby-Controlled Incubator cleared by the FDA?
Neocare Baby-Controlled Incubator (K813238) received a 510(k) decision of Substantially Equivalent on January 22, 1982, 66 days after the submission was received.
What is the product code of K813238?
The FDA product code is FMZ – Incubator, Neonatal, a Class II (moderate risk) device regulated under 21 CFR 880.5400.