The following data is part of a premarket notification filed by Philips Medizin Systeme Boeblingen Gmbh with the FDA for New: Intellivue Cl Respiration Pod New: Specialized Assessory: Mobile Cl Resp Attachment Modified: Intellivue Patient Mo.
| Device ID | K122223 |
| 510k Number | K122223 |
| Device Name: | NEW: INTELLIVUE CL RESPIRATION POD NEW: SPECIALIZED ASSESSORY: MOBILE CL RESP ATTACHMENT MODIFIED: INTELLIVUE PATIENT MO |
| Classification | Monitor, Breathing Frequency |
| Applicant | PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH HEWLETT-PACKARD STR. 2 Boeblingen, DE 71034 |
| Contact | Markus Stacha |
| Correspondent | Markus Stacha PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH HEWLETT-PACKARD STR. 2 Boeblingen, DE 71034 |
| Product Code | BZQ |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-25 |
| Decision Date | 2013-04-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884838033805 | K122223 | 000 |