The following data is part of a premarket notification filed by Litton Medical Electronics with the FDA for Sevomed Compact Monitor Smk 154-.
Device ID | K832095 |
510k Number | K832095 |
Device Name: | SEVOMED COMPACT MONITOR SMK 154- |
Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
Applicant | LITTON MEDICAL ELECTRONICS 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | DRT |
CFR Regulation Number | 870.2300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-06-28 |
Decision Date | 1984-03-22 |