INTELLIVUE PATIENT MONITOR
FDA 510(k) clearance K110622 · decided 2011-03-31
Clearance details
- K-number
- K110622
- Device name
- INTELLIVUE PATIENT MONITOR
- Applicant
- Philips Medizinsysteme Boeblingen GmbH, Cardiac AN
- Decision
- Substantially Equivalent
- Date received
- 2011-03-03
- Decision date
- 2011-03-31
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- MHX
- Device class
- 2
- Regulation number
- 870.1025
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Boeblingen, Baden-Wuerttemberg, DE
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Philips Medizinsysteme Boeblingen GmbH
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Lithium Ion Battery M4605A and M4607A for use with IntelliVue Patient Monitors. The monito recall (Z-1628-2014) | Philips Medical Systems, Inc. | 2014-05-16 |
| Philips IntelliVue Patient Monitors: The monitor is intended to be used for monitoring and recall (Z-1134-2012) | Philips Healthcare Inc. | 2012-03-01 |