Preemicare Model D1-X1, Series 3000
FDA 510(k) K881476 · Preemicare Corp.
510(k) numberK881476
Submission
- Device name
- Preemicare Model D1-X1, Series 3000
- Applicant
- Preemicare Corp.
Houston, TX, US - Received
- April 7, 1988
- Decision date
- December 8, 1988
- 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 |
|---|---|---|
| K911450 | Infant VentilatorCBK · Traditional | 06/18/1991SE |
| K896375 | Preemicare Nebutech Nebulizer SystemCAF · Traditional | 10/29/1990SE |
| K900735 | Model 130 Automatic Height Adjust (Aha) IncubatorFMZ · Traditional | 05/02/1990SE |
| K893622 | Preemicare Model 200-II Infant Transport Ventil.CBK · Traditional | 01/03/1990SE |
| K893624 | Preemicare Model 2500 Transport WarmerFPL · Traditional | 09/27/1989SE |
| K891674 | Neonatal Environmental Monitor, Model 275CCL · Traditional | 08/31/1989SE |
| K885350 | Preemicare Series 2000 Infant WarmerFMT · Traditional | 08/07/1989SE |
| K884133 | Preemicare Series 4000 Phototherapy LampLBI · Traditional | 03/08/1989SE |
Questions and answers
When was Preemicare Model D1-X1, Series 3000 cleared by the FDA?
Preemicare Model D1-X1, Series 3000 (K881476) received a 510(k) decision of Substantially Equivalent on December 8, 1988, 245 days after the submission was received.
What is the product code of K881476?
The FDA product code is FMZ – Incubator, Neonatal, a Class II (moderate risk) device regulated under 21 CFR 880.5400.