The following data is part of a premarket notification filed by Intl. Medical, Inc. with the FDA for Cardiac Wall Motion Device.
Device ID | K833728 |
510k Number | K833728 |
Device Name: | CARDIAC WALL MOTION DEVICE |
Classification | Plethysmograph, Impedance |
Applicant | INTL. MEDICAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DSB |
CFR Regulation Number | 870.2770 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-10-25 |
Decision Date | 1984-02-10 |