The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics with the FDA for Measurement Of Ph In Pleural Fluid On Blood Gas System.
| Device ID | K122539 |
| 510k Number | K122539 |
| Device Name: | MEASUREMENT OF PH IN PLEURAL FLUID ON BLOOD GAS SYSTEM |
| Classification | Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS 2 EDGEWATER DRIVE Norwood, MA 02062 |
| Contact | Steven Goldberg |
| Correspondent | Steven Goldberg SIEMENS HEALTHCARE DIAGNOSTICS 2 EDGEWATER DRIVE Norwood, MA 02062 |
| Product Code | CHL |
| CFR Regulation Number | 862.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-21 |
| Decision Date | 2013-04-19 |
| Summary: | summary |