The following data is part of a premarket notification filed by Litton Medical Electronics with the FDA for Multiscriptor Ek Various #43.
Device ID | K832015 |
510k Number | K832015 |
Device Name: | MULTISCRIPTOR EK VARIOUS #43 |
Classification | Electrocardiograph |
Applicant | LITTON MEDICAL ELECTRONICS 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | DPS |
CFR Regulation Number | 870.2340 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-06-23 |
Decision Date | 1983-10-31 |