The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics, Inc. with the FDA for Rapidpoint 500e Blood Gas System.
| Device ID | K192240 |
| 510k Number | K192240 |
| Device Name: | RAPIDPoint 500e Blood Gas System |
| Classification | Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph |
| Applicant | Siemens Healthcare Diagnostics, Inc. 2 Edgewater Drive Norwood, MA 02062 |
| Contact | Lois Parillon |
| Correspondent | Lois Parillon Siemens Healthcare Disgnostics, Inc. 2 Edgewater Drive Norwood, MA 02062 |
| Product Code | CHL |
| Subsequent Product Code | CEM |
| Subsequent Product Code | CGA |
| Subsequent Product Code | CGZ |
| Subsequent Product Code | GKR |
| Subsequent Product Code | JFP |
| Subsequent Product Code | JGS |
| Subsequent Product Code | KHP |
| Subsequent Product Code | MQM |
| CFR Regulation Number | 862.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-19 |
| Decision Date | 2020-03-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414286143 | K192240 | 000 |
| 00630414609515 | K192240 | 000 |