510(k) K191425
- Device
- Hydro-Temp Neonatal Skin Temperature Probe Cover
- Applicant
- DeRoyal Industries, Inc.
- 510(k) number
- K191425
- Product code
- FMT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2020-01-21
- Date received
- 2019-05-29
- Regulation
- 880.5130
- Classification name
- Warmer, Infant Radiant
- 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
- Sarah Bennett
- Address
- 200 Debusk Ln. Powell TN US 37849 37849
FDA Registration Numbers#
- 1055236
- 2510954
- 1000617661
- 2085602
- 1625392
- 3036470679
- 1054713
- 3007734888
- 3008729547
- 9617277
- 3005652389
- 1057358
- 9613793
- 1226711
- 1043214
- 1314417
- 9710602
- 3012348048
- 3012086037
- 3004050971
- 3021559257
- 2027062
- 3005934741
- 1054241
- 1317188
- 1034876
- 3001104093
- 3010838917
- 3030733800
- 9611500
- 9611451
- 1000604079
- 3014220748
Source Documents#
Other 510(k) Records For Product Code FMT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243606 | Babyroo TN300 | Draeger Medical Systems, Inc. | 2025-01-17 |
| K230278 | Babyroo TN300 | Draeger Medical Systems, Inc. | 2023-05-30 |
| K213551 | Giraffe Omnibed Carestation CS1 | Datex Ohmeda, Inc. | 2022-03-02 |
| K201628 | Panda iRes Warmer, Giraffe Warmer | GE Healthcare | 2021-02-12 |
| K200319 | HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface Cable | Deroyal Industries, Inc. | 2020-04-02 |
| K173516 | NuBorne Infant Warmer | International Biomedical | 2018-08-17 |
| K123309 | GIRAFFE AND PANDA WARMERS | Ohmeda Medical | 2013-02-05 |
| K120642 | RESUSCITAIRE WITH AUTOBREATH | Draeger Medical Systems, Inc. | 2012-11-02 |
| K122267 | GIRAFFE AND PANDA WARMERS | Ohmeda Medical, A Division of Datex-Ohmeda, Inc. | 2012-10-02 |
| K121625 | LULLABY TM WARMER | Wipro GE Healthcare Private, Ltd. | 2012-09-14 |
| K120937 | SUNFLOWER WARNER | Atom Medical Corporation | 2012-07-06 |
| K102227 | INFA WARMER I | Atom Medical Corporation | 2011-01-21 |
| K101804 | GIRAFFE AND PANDA WARMERS | Ohmeda Medical, A Division of Datex-Ohmeda, Inc. | 2010-07-21 |
| K090697 | MODIFICATION TO: GIRAFFE AND PANDA WARMER | Ohmeda Medical | 2009-04-16 |
| K072157 | MODIFICATION TO GIRAFFE AND PANDA WARMERS (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY) | Ohmeda Medical | 2007-08-27 |
Legacy Summary#
summary
FDA Review#
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