Vitalograph EC-50 Carbon Monoxide Monitor
FDA 510(k) K863420 · Vitalograph , Ltd.
510(k) numberK863420
Submission
- Device name
- Vitalograph EC-50 Carbon Monoxide Monitor
- Applicant
- Vitalograph , Ltd.
Lenexa, KS, US - Received
- September 4, 1986
- Decision date
- January 15, 1987
- 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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| K130036 | Cosense Co MonitorCCJ · Traditional | Capnia, Inc. | 01/14/2014SE |
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|---|---|---|
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| K991412 | Vitalograph MicroBZH · Traditional | 02/04/2000SE |
| K943678 | Electronic Flow MeterBZH · Traditional | 12/14/1995SE |
| K950854 | Vitalograph 2110 Software InterfaceDSH · Traditional | 10/12/1995SE |
| K946075 | Vitalograph Model 2120BZG · Traditional | 08/04/1995SE |
| K942779 | Disposable Bacteriological FilterBZG · Traditional | 07/13/1994SE |
| K925085 | Escort SpirometerBZG · Traditional | 08/12/1993SE |
| K930085 | Vitalograph Data Storage SpirometerBTY · Traditional | 07/26/1993SE |
| K912412 | Vitalograph Spirotrac IIIBZG · Traditional | 10/15/1991SE |
Questions and answers
When was Vitalograph EC-50 Carbon Monoxide Monitor cleared by the FDA?
Vitalograph EC-50 Carbon Monoxide Monitor (K863420) received a 510(k) decision of Substantially Equivalent on January 15, 1987, 133 days after the submission was received.
What is the product code of K863420?
The FDA product code is CCJ – Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase, a Class II (moderate risk) device regulated under 21 CFR 868.1430.