510(k) K132543
- Device
- INFANT INCUBATOR
- Applicant
- BISTOS CO., LTD.
- 510(k) number
- K132543
- Product code
- FMZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-07-03
- Date received
- 2013-08-13
- Regulation
- 880.5400
- Classification name
- Incubator, Neonatal
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- YOUNG CHI
- Address
- 27 New England Dr. Ramsey NJ US 07446 07446
FDA Registration Numbers#
- 1055236
- 2510954
- 3009077524
- 3036470679
- 1054713
- 3007734888
- 3006179052
- 3008729547
- 3005652389
- 1066270
- 9613793
- 1226711
- 1043214
- 1000122786
- 9710602
- 3012348048
- 3021559257
- 3005934741
- 1054241
- 3030089838
- 1034876
- 3001104093
- 9611500
- 3014220748
Source Documents#
Other 510(k) Records For Product Code FMZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251619 | Babyleo TN500 | Drägerwerk AG & Co. KGaA | 2026-02-13 |
| K251663 | Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1) | Datex-Ohmeda, Inc. | 2025-10-22 |
| K243437 | mOm Essential Incubator (ME1) | Mom Incubators Limited | 2025-08-14 |
| K213553 | Giraffe Incubator Carestation CS1 | Datex Ohmeda, Inc. | 2022-03-02 |
| K190494 | Infant Incubator | Ningbo David Medical Device Co., Ltd. | 2019-11-25 |
| K182859 | Babyleo TN500 | Dragerwerk AG & CO Kgaa | 2019-02-22 |
| K182977 | Isolette 8000 Plus | Draeger Medical Systems, Inc. | 2018-11-21 |
| K172154 | Isolette 8000 plus | Draeger Medical Sytems, Inc. | 2018-04-19 |
| K162821 | Babyleo TN500 | Draegerwerk AG & CO Kgaa | 2017-06-23 |
| K152814 | Giraffe OmniBed Carestation CS1 | Ohmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Company | 2016-03-17 |
| K152809 | Giraffe Incubator Carestation CS1 | Ohmeda Medical, A Division of Datex-Ohmeda, Inc. | 2015-12-31 |
| K102226 | DUAL INCU I | Atom Medical Corporation | 2011-01-04 |
| K102279 | INCU I | Atom Medical Corporation | 2010-12-29 |
| K102710 | NEO-SERVO I | Atom Medical Corporation | 2010-12-22 |
| K101778 | GIRAFFE INCUBATOR | Ohmeda Medical | 2010-07-21 |
Legacy Summary#
summary
FDA Review#
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