The following data is part of a premarket notification filed by Marquest Medical Products, Inc. with the FDA for Minolta/marquest Pulsox-7 Oxygen Saturation Monit..
Device ID | K863918 |
510k Number | K863918 |
Device Name: | MINOLTA/MARQUEST PULSOX-7 OXYGEN SATURATION MONIT. |
Classification | Oximeter |
Applicant | MARQUEST MEDICAL PRODUCTS, INC. 11039 EAST LANSING CIR. Englewood, CO 80112 |
Contact | R. J Mckinnon |
Correspondent | R. J Mckinnon MARQUEST MEDICAL PRODUCTS, INC. 11039 EAST LANSING CIR. Englewood, CO 80112 |
Product Code | DQA |
CFR Regulation Number | 870.2700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-10-08 |
Decision Date | 1987-01-07 |