The following data is part of a premarket notification filed by Phoenix Diagnostics, Inc. with the FDA for Co-oximeter Controls.
| Device ID | K901986 |
| 510k Number | K901986 |
| Device Name: | CO-OXIMETER CONTROLS |
| Classification | Controls For Blood-gases, (assayed And Unassayed) |
| 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 | JJS |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-02 |
| Decision Date | 1990-05-31 |