The following data is part of a premarket notification filed by Phoenix Diagnostics, Inc. with the FDA for Spectrum Co-oximeter Linearity Control.
| Device ID | K945860 |
| 510k Number | K945860 |
| Device Name: | SPECTRUM CO-OXIMETER LINEARITY CONTROL |
| Classification | Controls For Blood-gases, (assayed And Unassayed) |
| Applicant | PHOENIX DIAGNOSTICS, INC. 8 TECH CIRCLE Natick, MA 01760 |
| Contact | Ram Nunna |
| Correspondent | Ram Nunna PHOENIX DIAGNOSTICS, INC. 8 TECH CIRCLE Natick, MA 01760 |
| Product Code | JJS |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-01 |
| Decision Date | 1995-01-17 |