Isolette Infant Incubator, Model C2HS
FDA 510(k) K001242 · Hill-Rom Air-Shields
510(k) numberK001242
Submission
- Device name
- Isolette Infant Incubator, Model C2HS
- Applicant
- Hill-Rom Air-Shields
Hatboro, PA, US - Received
- April 18, 2000
- Decision date
- July 13, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|
| K021622 | Hill-Rom Air Shields/Minolta Jaundice Meter, Model JM-103MQM · Traditional | 04/01/2003SE |
| K003335 | Resuscitaire Radiant Warmer; Resuscitaire Birthing Room Warmer; Resuscitair Wall Mounted…FMT · Special | 11/17/2000SE |
| K001019 | TI500 Globe-Trotter Transport SystemFPL · Traditional | 04/27/2000SE |
| K993051 | Versalet 7700 Care Center, Model # 7700FMZ · Traditional | 02/03/2000SE |
Questions and answers
When was Isolette Infant Incubator, Model C2HS cleared by the FDA?
Isolette Infant Incubator, Model C2HS (K001242) received a 510(k) decision of Substantially Equivalent on July 13, 2000, 86 days after the submission was received.
What is the product code of K001242?
The FDA product code is FMZ – Incubator, Neonatal, a Class II (moderate risk) device regulated under 21 CFR 880.5400.