Diffusion Option, Omni-Lab
FDA 510(k) K781871 · Ohio Medical Products
510(k) numberK781871
Submission
- Device name
- Diffusion Option, Omni-Lab
- Applicant
- Ohio Medical Products
Mchenry, IL, US - Received
- November 3, 1978
- Decision date
- January 2, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CCJ – Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1430
- Specialty
- Anesthesiology
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| K151107 | CoSense ETCO MonitorCCJ · Special | Capnia, Inc. | 07/22/2015SE |
| K130036 | Cosense Co MonitorCCJ · Traditional | Capnia, Inc. | 01/14/2014SE |
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| K082315 | EC50 Micro+ SmokerlyzerCCJ · Traditional | Bedfont Scientific, Ltd. | 02/01/2010SE |
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|---|---|---|
| K841733 | Ohio Waste Gas Scavenging ReservoirCBN · Traditional | 07/11/1984SE |
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| 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 |
| K840857 | Ohio 3000 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 |
Questions and answers
When was Diffusion Option, Omni-Lab cleared by the FDA?
Diffusion Option, Omni-Lab (K781871) received a 510(k) decision of Substantially Equivalent on January 2, 1979, 60 days after the submission was received.
What is the product code of K781871?
The FDA product code is CCJ – Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase, a Class II (moderate risk) device regulated under 21 CFR 868.1430.