Neocare Temperature Monitor
FDA 510(k) K810792 · Vickers America Medical Corp.
510(k) numberK810792
Submission
- Device name
- Neocare Temperature Monitor
- Applicant
- Vickers America Medical Corp.
Mchenry, IL, US - Received
- March 23, 1981
- Decision date
- April 29, 1981
- 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
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| K251663 | Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)FMZ · Traditional | Datex-Ohmeda, Inc. | 10/22/2025SE |
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| K213553 | Giraffe Incubator Carestation CS1FMZ · Traditional | Datex Ohmeda, Inc. | 03/02/2022SE |
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| 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 |
| K813238 | Neocare Baby-Controlled IncubatorFMZ · Traditional | 01/22/1982SE |
| K811865 | Vma Pediatric Apnea MattressBZQ · Traditional | 07/31/1981SE |
| 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 Temperature Monitor cleared by the FDA?
Neocare Temperature Monitor (K810792) received a 510(k) decision of Substantially Equivalent on April 29, 1981, 37 days after the submission was received.
What is the product code of K810792?
The FDA product code is FMZ – Incubator, Neonatal, a Class II (moderate risk) device regulated under 21 CFR 880.5400.