The following data is part of a premarket notification filed by Marquest Medical Products, Inc. with the FDA for Minolta Sm-32 Oxygen Saturation Monit.
Device ID | K833973 |
510k Number | K833973 |
Device Name: | MINOLTA SM-32 OXYGEN SATURATION MONIT |
Classification | Oximeter |
Applicant | MARQUEST MEDICAL PRODUCTS, INC. 112 Inverness Circle Suite A Englewood, CO 80112 |
Contact | R.j. Mckinnon |
Correspondent | R.j. Mckinnon MARQUEST MEDICAL PRODUCTS, INC. 112 Inverness Circle Suite A 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 | 1983-11-16 |
Decision Date | 1984-05-09 |