The following data is part of a premarket notification filed by Medical Measurements, Inc. with the FDA for Mmi/gaeltec Series 8t Diff. Press. Trans.
Device ID | K801880 |
510k Number | K801880 |
Device Name: | MMI/GAELTEC SERIES 8T DIFF. PRESS. TRANS |
Classification | Transducer, Gas Pressure, Differential |
Applicant | MEDICAL MEASUREMENTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | BYR |
CFR Regulation Number | 868.2875 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-08-07 |
Decision Date | 1980-08-14 |