CAS 740 SERIES MONITOR, MODELS 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL, 740M-2NL, 740-2NN, 740M-2NN, 740-3MS, 740M-3MS
FDA 510(k) clearance K033048 · decided 2004-06-01
Clearance details
- K-number
- K033048
- Device name
- CAS 740 SERIES MONITOR, MODELS 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL, 740M-2NL, 740-2NN, 740M-2NN, 740-3MS, 740M-3MS
- Applicant
- Cas Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-09-29
- Decision date
- 2004-06-01
- Days to decision
- 246 days
- Clearance type
- Special
- Product code
- MHX
- Device class
- 2
- Regulation number
- 870.1025
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Branford, CT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| 740 Series Multiparameter Monitor Software Version 3.0 Model Numbers: 740-1, 740M-1, 740-2 recall (Z-2203-2008) | CAS Medical Systems, Inc. | 2008-09-16 |