The following data is part of a premarket notification filed by Medasonics, Inc. with the FDA for Mod. Mci 17 Manual Cuff Inflator.
Device ID | K800767 |
510k Number | K800767 |
Device Name: | MOD. MCI 17 MANUAL CUFF INFLATOR |
Classification | Blood Pressure Cuff |
Applicant | MEDASONICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DXQ |
CFR Regulation Number | 870.1120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-04-07 |
Decision Date | 1980-04-24 |