The following data is part of a premarket notification filed by Waters Assoc., Inc. with the FDA for Mrm-2 Oxygen Consumption Monitor.
Device ID | K801852 |
510k Number | K801852 |
Device Name: | MRM-2 OXYGEN CONSUMPTION MONITOR |
Classification | Computer, Oxygen-uptake |
Applicant | WATERS ASSOC., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | BZL |
CFR Regulation Number | 868.1730 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-08-04 |
Decision Date | 1980-08-20 |