The following data is part of a premarket notification filed by Nidek Medical Products, Inc. with the FDA for Oxychek Oxygen Analyzer.
| Device ID | K942593 |
| 510k Number | K942593 |
| Device Name: | OXYCHEK OXYGEN ANALYZER |
| Classification | Analyzer, Gas, Oxygen, Gaseous-phase |
| Applicant | NIDEK MEDICAL PRODUCTS, INC. 3949 VALLEY EAST INDUSTRIAL DR Birmingham, AL 35217 |
| Contact | Gregg Gaskins |
| Correspondent | Gregg Gaskins NIDEK MEDICAL PRODUCTS, INC. 3949 VALLEY EAST INDUSTRIAL DR Birmingham, AL 35217 |
| Product Code | CCL |
| CFR Regulation Number | 868.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-01 |
| Decision Date | 1995-05-03 |