Biliblanket Plus High Output Phototherapy System
FDA 510(k) K993712 · Ohmeda Medical
510(k) numberK993712
Submission
- Device name
- Biliblanket Plus High Output Phototherapy System
- Applicant
- Ohmeda Medical
Columbia, MD, US - Received
- November 3, 1999
- Decision date
- November 9, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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
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| K123309 | Giraffe and Panda WarmersFMT · Traditional | 02/05/2013SE |
| K101788 | Giraffe OmnibedFMZ · Special | 07/21/2010SE |
| K101778 | Giraffe IncubatorFMZ · Special | 07/21/2010SE |
| K090697 | Modification to: Giraffe and Panda WarmerFMT · Special | 04/16/2009SE |
| K072157 | Modification to Giraffe and Panda Warmers (Giraffe and Panda Uninterruptible Power Supply)FMT · Special | 08/27/2007SE |
| K070377 | Giraffe and Panda WarmerFMT · Traditional | 07/11/2007SE |
| K070247 | Giraffe and Panda Bag and Mask Resuscitation SystemBTM · Traditional | 04/20/2007SE |
| K070210 | Giraffe and Panda T- Piece Resuscitation SystemBTL · Traditional | 04/20/2007SE |
| K040068 | Biliblanket Plus High Output Phototherapy SystemFMZ · Traditional | 04/16/2004SE |
| K020547 | Ohmeda Medical Giraffe IncubatorFMZ · Traditional | 05/09/2002SE |
Questions and answers
When was Biliblanket Plus High Output Phototherapy System cleared by the FDA?
Biliblanket Plus High Output Phototherapy System (K993712) received a 510(k) decision of Substantially Equivalent on November 9, 1999, 6 days after the submission was received.
What is the product code of K993712?
The FDA product code is FMZ – Incubator, Neonatal, a Class II (moderate risk) device regulated under 21 CFR 880.5400.