Intellivue CL Respiration Pod
FDA 510(k) K132320 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN
510(k) numberK132320
Submission
- Device name
- Intellivue CL Respiration Pod
- Applicant
- Philips Medizinsysteme Boeblingen GmbH, Cardiac AN
Boeblingen, Baden-Wuerttemberg, DE - Received
- July 25, 2013
- Decision date
- March 26, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BZQ – Monitor, Breathing Frequency
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.2375
- Specialty
- Anesthesiology
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More from Linshom Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K141015 | Intellivue Patient Monitor MX400, Intellivue Patient Monitor MX450, Intellivue Patient…MHX · Special | 05/19/2014SE |
| K131872 | Intellivue Patient Monitor MX500, Intellivue Patient Monitor MX550MHX · Special | 10/17/2013SE |
| K131829 | Intellivue Patient MonitorMHX · Special | 08/16/2013SE |
| K130849 | Intellivue Patient Monitor MX400; Intellivue Patient Monitor MX450MHX · Special | 06/14/2013SE |
| K120366 | Intellivue Patient MonitorMHX · Abbreviated | 07/18/2012SE |
| K113441 | Physiological Monitor, Patient MonitorMHX · Traditional | 03/22/2012SE |
| K111905 | Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model 865215…DXJ · Abbreviated | 10/04/2011SE |
| K110474 | Philips Intellivue TCG10LKD · Abbreviated | 09/30/2011SE |
| K111083 | Philips Avalon Fetal/Maternal Monitors FM20, FM30, FM40 and FM50HGM · Abbreviated | 08/17/2011SE |
| K110622 | Intellivue Patient MonitorMHX · Special | 03/31/2011SE |
Questions and answers
When was Intellivue CL Respiration Pod cleared by the FDA?
Intellivue CL Respiration Pod (K132320) received a 510(k) decision of Substantially Equivalent on March 26, 2014, 244 days after the submission was received.
What is the product code of K132320?
The FDA product code is BZQ – Monitor, Breathing Frequency, a Class II (moderate risk) device regulated under 21 CFR 868.2375.