The following data is part of a premarket notification filed by Phoenix Diagnostics, Inc. with the FDA for Blood Gases/pc02, Po2 Analysis Products.
| Device ID | K902267 |
| 510k Number | K902267 |
| Device Name: | BLOOD GASES/PC02, PO2 ANALYSIS PRODUCTS |
| Classification | Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph |
| Applicant | PHOENIX DIAGNOSTICS, INC. 93 WEST ST. Medfield, MA 02052 |
| Contact | Ram Nunna |
| Correspondent | Ram Nunna PHOENIX DIAGNOSTICS, INC. 93 WEST ST. Medfield, MA 02052 |
| Product Code | CHL |
| CFR Regulation Number | 862.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-21 |
| Decision Date | 1990-06-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10852676009774 | K902267 | 000 |
| 10852676007053 | K902267 | 000 |
| 01085267600704 | K902267 | 000 |
| 10852676007022 | K902267 | 000 |
| 10852676007060 | K902267 | 000 |