The following data is part of a premarket notification filed by D.r.g. Scientific Industries with the FDA for Co-oximeter Solutions.
| Device ID | K863825 |
| 510k Number | K863825 |
| Device Name: | CO-OXIMETER SOLUTIONS |
| Classification | Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-monoxide |
| Applicant | D.R.G. SCIENTIFIC INDUSTRIES 1140 SARATOGA ST. East Boston, MA 02128 |
| Contact | Vincent E Corsano |
| Correspondent | Vincent E Corsano D.R.G. SCIENTIFIC INDUSTRIES 1140 SARATOGA ST. East Boston, MA 02128 |
| Product Code | JKS |
| CFR Regulation Number | 862.3220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-30 |
| Decision Date | 1986-11-24 |