SMARTMONITOR 2 PROFESSIONAL SERIES (PS)
FDA 510(k) clearance K032403 · decided 2003-10-27
Clearance details
- K-number
- K032403
- Device name
- SMARTMONITOR 2 PROFESSIONAL SERIES (PS)
- Applicant
- Respironics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-08-04
- Decision date
- 2003-10-27
- Days to decision
- 84 days
- Clearance type
- Abbreviated
- Product code
- NPF
- Device class
- 2
- Regulation number
- 868.2377
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Murrysville, PA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SMARTMONITOR 2PS (K061256) | Respironics, Inc. | 2006-08-02 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Oximeter Patient Cable Masimo 8 ft model number H5870. Filter, mask, and/or accessories fo recall (Z-1091-2008) | Respironics, Inc. | 2008-04-24 |