SMARTMONITOR 2PS
FDA 510(k) clearance K061256 · decided 2006-08-02
Clearance details
- K-number
- K061256
- Device name
- SMARTMONITOR 2PS
- Applicant
- Respironics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-05-04
- Decision date
- 2006-08-02
- Days to decision
- 90 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 2 PROFESSIONAL SERIES (PS) (K032403) | Respironics, Inc. | 2003-10-27 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Philips/Children's Medical Ventures Smart Monitor 2 Professional Series infant apnea monit recall (Z-1789-2014) | Childrens Medical Ventures | 2014-06-13 |
| APNEA monitor accessories under the following brand names: a) SM 2 PS/PSL, Prof. Operators recall (Z-1086-2008) | Respironics, Inc. | 2008-04-24 |