Oxygen Monitor OM-100 & Oxygen Probe OP-100
FDA 510(k) K853786 · American Bentley
510(k) numberK853786
Submission
- Device name
- Oxygen Monitor OM-100 & Oxygen Probe OP-100
- Applicant
- American Bentley
Irvine, CA, US - Received
- September 10, 1985
- Decision date
- October 16, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CCE – Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1200
- Specialty
- Anesthesiology
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|---|---|---|
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| K870269 | Electrosurgical Meniscus Cutter (Emc) Mod. AMC-100GEI · Traditional | 03/09/1987SE |
| K863249 | Oxygenator Model No. BENTLEY-10 PlusDTZ · Traditional | 10/20/1986SE |
| K861641 | Heparin-Coated Extracorporeal CircuitsDTZ · Traditional | 09/29/1986SE |
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Questions and answers
When was Oxygen Monitor OM-100 & Oxygen Probe OP-100 cleared by the FDA?
Oxygen Monitor OM-100 & Oxygen Probe OP-100 (K853786) received a 510(k) decision of Substantially Equivalent on October 16, 1985, 36 days after the submission was received.
What is the product code of K853786?
The FDA product code is CCE – Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling, a Class II (moderate risk) device regulated under 21 CFR 868.1200.