510(k) K171129
- Device
- CO Check Pro, CO Screen
- Applicant
- MD Diagnostics Limited
- 510(k) number
- K171129
- Product code
- CCJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-03-02
- Date received
- 2017-04-17
- Regulation
- 868.1430
- Classification name
- Analyzer, Gas, Carbon-monoxide, Gaseous-phase
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Glen Hillsley
- Address
- 15 Hollingworth Ct., Turkey Mill Maidstone GB ME14 5PP ME14 5PP
FDA Registration Numbers#
- 3009896423
- 3033509895
- 3033959233
- 9612890
- 3002808458
- 3002622685
- 9615102
- 3005053770
- 1223858
- 3014023337
- 3008614998
Source Documents#
Other 510(k) Records For Product Code CCJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253119 | CoSense ETCO Monitor | Capnia, Inc. | 2026-05-29 |
| K211918 | iCOquit® Smokerlyzer® | Bedfont Scientific, Ltd. | 2021-12-21 |
| K201206 | Pivot Breath Sensor | Carrot, Inc. | 2021-06-30 |
| K173238 | ToxCO | Bedfont Scientific, Ltd. | 2019-04-04 |
| K171408 | Carbon Monoxide Breath Sensor System (COBSS) | Carrot Sense, Inc. | 2017-09-29 |
| K151107 | CoSense ETCO Monitor | Capnia, Inc. | 2015-07-22 |
| K130036 | COSENSE CO MONITOR | Capnia, Inc. | 2014-01-14 |
| K121768 | COSENSE | Capnia, Inc. | 2012-10-31 |
| K082315 | EC50 MICRO+ SMOKERLYZER | Bedfont Scientific, Ltd. | 2010-02-01 |
| K080278 | TABATABA COTESTER | Fim Medical | 2008-11-28 |
| K070259 | EC50 TOXCO+ BREATH CARBON MONOXIDE MONITOR | Bedfont Scientific, Ltd. | 2008-02-21 |
| K000962 | PICO SMOKERLYZER, MODEL EC-50 | Bedfont Scientific, Ltd. | 2000-04-20 |
| K950197 | MICROCO | Micro Direct, Inc. | 1996-10-17 |
| K952694 | CO BREATH ANALYSIS MODULE & MONOXOL II | Bacharach, Inc. | 1996-01-29 |
| K904633 | SPIROLOOP, MODIFICATION | Pneumedics, Inc. | 1991-03-12 |
Legacy Summary#
summary
FDA Review#
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