The following data is part of a premarket notification filed by Marquest Medical Products, Inc. with the FDA for Marquest Qc-iv Tonometer.
| Device ID | K855024 |
| 510k Number | K855024 |
| Device Name: | MARQUEST QC-IV TONOMETER |
| Classification | Controls For Blood-gases, (assayed And Unassayed) |
| Applicant | MARQUEST MEDICAL PRODUCTS, INC. 11039 EAST LANSING CIR. Englewood, CO 80112 |
| Contact | Robert J Mckinnon |
| Correspondent | Robert J Mckinnon MARQUEST MEDICAL PRODUCTS, INC. 11039 EAST LANSING CIR. Englewood, CO 80112 |
| Product Code | JJS |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-17 |
| Decision Date | 1986-04-07 |