510(k) K952694
- Device
- Co Breath Analysis Module & Monoxol Ii
- Applicant
- BACHARACH, INC.
- 510(k) number
- K952694
- Product code
- CCJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-01-29
- Date received
- 1995-06-14
- 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
- EDWARD MARCH
- Address
- 7475 Wisconsin Ave., Suite 850 Bethesda MD US 20814 20814
FDA Registration Numbers#
- 3033509895
- 3002808458
- 3014023337
- 1223858
- 3005053770
- 3033959233
- 9612890
- 9615102
- 3002622685
- 3009896423
- 3008614998
Source Documents#
Other 510(k) Records For Product Code CCJ#
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| 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 |
| K904633 | SPIROLOOP, MODIFICATION | Pneumedics, Inc. | 1991-03-12 |
| K902113 | VITALOGRAPH - BREATHCO MONITOR | Mcneill Intl., Inc. | 1990-10-26 |