The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics with the FDA for Rapidpoint 500 Blood Gas Analyer.
| Device ID | K113216 |
| 510k Number | K113216 |
| Device Name: | RAPIDPOINT 500 BLOOD GAS ANALYER |
| Classification | Acid, Lactic, Enzymatic Method |
| 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 | KHP |
| CFR Regulation Number | 862.1450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-01 |
| Decision Date | 2012-05-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414589169 | K113216 | 000 |