Ohio 3000 Infant Warmer System
FDA 510(k) K840857 · Ohio Medical Products
510(k) numberK840857
Submission
- Device name
- Ohio 3000 Infant Warmer System
- Applicant
- Ohio Medical Products
Walker, MI, US - Received
- February 24, 1984
- Decision date
- March 23, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FMT – Warmer, Infant Radiant
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5130
- Specialty
- General Hospital
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More from Ohmeda Medical, A Division of Datex-Ohmeda, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K841733 | Ohio Waste Gas Scavenging ReservoirCBN · Traditional | 07/11/1984SE |
| K842003 | Ohio Waste Gas Scavenging InterfaceCBN · Traditional | 05/23/1984SE |
| K840356 | Ohio Unitrol II Anesthesia Gas MachineBSZ · Traditional | 04/20/1984SE |
| K841274 | Bag-To-Ventilator Selector ValveBSZ · Traditional | 04/13/1984SE |
| K840967 | Ohio Heat Reflecting PatchFMI · Traditional | 03/23/1984SE |
| K840858 | Ohio 3300 Infant Warmer SystemFMT · Traditional | 03/23/1984SE |
| K840453 | Medishield PVM RespirometerBZK · Traditional | 03/02/1984SE |
| K840452 | Premium Dabm Dispos. Anes. Breath MaskBSJ · Traditional | 02/17/1984SE |
| K833335 | Modulus II Anesthesia Gas MachineBSZ · Traditional | 11/14/1983SE |
| K830488 | Ventilator #1CBK · Traditional | 09/15/1983SE |
Questions and answers
When was Ohio 3000 Infant Warmer System cleared by the FDA?
Ohio 3000 Infant Warmer System (K840857) received a 510(k) decision of Substantially Equivalent on March 23, 1984, 28 days after the submission was received.
What is the product code of K840857?
The FDA product code is FMT – Warmer, Infant Radiant, a Class II (moderate risk) device regulated under 21 CFR 880.5130.