CO/CMD-1
FDA 510(k) K900322 · Spirometrics, Inc.
510(k) numberK900322
Submission
- Device name
- CO/CMD-1
- Applicant
- Spirometrics, Inc.
Auburn, ME, US - Received
- January 23, 1990
- Decision date
- April 30, 1990
- 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
Other 510(k)s with product code CCJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253119 | CoSense ETCO MonitorCCJ · Traditional | Capnia, Inc. | 05/29/2026SE |
| K211918 | iCOquit® Smokerlyzer®CCJ · Traditional | Bedfont Scientific, Ltd. | 12/21/2021SE |
| K201206 | Pivot Breath SensorCCJ · Traditional | Carrot, Inc. | 06/30/2021SE |
| K173238 | ToxCOCCJ · Traditional | Bedfont Scientific, Ltd. | 04/04/2019SE |
| K171129 | CO Check Pro, CO ScreenCCJ · Traditional | MD Diagnostics Limited | 03/02/2018SE |
| K171408 | Carbon Monoxide Breath Sensor System (COBSS)CCJ · Traditional | Carrot Sense, Inc. | 09/29/2017SE |
| K151107 | CoSense ETCO MonitorCCJ · Special | Capnia, Inc. | 07/22/2015SE |
| K130036 | Cosense Co MonitorCCJ · Traditional | Capnia, Inc. | 01/14/2014SE |
| K121768 | CosenseCCJ · Traditional | Capnia, Inc. | 10/31/2012SE |
| K082315 | EC50 Micro+ SmokerlyzerCCJ · Traditional | Bedfont Scientific, Ltd. | 02/01/2010SE |
More from Bedfont Scientific, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K915059 | Peak Flow MonitorBZH · Traditional | 07/27/1992SE |
| K911358 | Cmd/Dlco Diagnostic SpirometerBTY · Traditional | 07/22/1991SE |
| K901057 | Spirometrics Model 2600 Miro SpirometerBZG · Traditional | 04/03/1990SE |
| K900673 | Serial FlowBZG · Traditional | 04/03/1990SE |
| K884464 | Spirometrics Model 2200 SM200 Flow SensorJAX · Traditional | 01/19/1989SE |
| K884465 | Spirometrics Model 2141 Spiro-Filter(Tm)CAH · Traditional | 11/09/1988SE |
| K863953 | Spirometrics Model 2500 Flowmate(Tm)BZM · Traditional | 01/15/1987SE |
| K850045 | Spirometrics 2453 & Smi IIIBTY · Traditional | 02/14/1985SE |
| K844333 | Spirometrics 2451 & Smi IBZG · Traditional | 11/20/1984SE |
| K831497 | Spirometrics Breon 2400 & Smi 2400BZG · Traditional | 06/24/1983SE |
Questions and answers
When was CO/CMD-1 cleared by the FDA?
CO/CMD-1 (K900322) received a 510(k) decision of Substantially Equivalent on April 30, 1990, 97 days after the submission was received.
What is the product code of K900322?
The FDA product code is CCJ – Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase, a Class II (moderate risk) device regulated under 21 CFR 868.1430.