THE PHILIPS MP20,MP30,MP40,MP50,MP60,MP70,MP80 AND MP90 INTELLIVUE ATIENT MONITORS
FDA 510(k) clearance K060541 · decided 2006-03-24
Clearance details
- K-number
- K060541
- Device name
- THE PHILIPS MP20,MP30,MP40,MP50,MP60,MP70,MP80 AND MP90 INTELLIVUE ATIENT MONITORS
- Applicant
- Philips Medizin Systeme Boblingen GmbH
- Decision
- Substantially Equivalent
- Date received
- 2006-03-01
- Decision date
- 2006-03-24
- Days to decision
- 23 days
- Clearance type
- Special
- Product code
- MHX
- Device class
- 2
- Regulation number
- 870.1025
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Boblingen, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Philips M1013A IntelliVue G1 Anesthesia Gas Modules with manifolds recall (Z-2263-2010) | Philips Healthcare Inc. | 2010-08-24 |
| Philips M1019A IntelliVue G5 Anesthesia Gas Modules with manifolds recall (Z-2264-2010) | Philips Healthcare Inc. | 2010-08-24 |