The following data is part of a premarket notification filed by Litton Medical Electronics with the FDA for Servomed Compact Monitor Smk 155-9.
Device ID | K832035 |
510k Number | K832035 |
Device Name: | SERVOMED COMPACT MONITOR SMK 155-9 |
Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
Applicant | LITTON MEDICAL ELECTRONICS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DRT |
CFR Regulation Number | 870.2300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-06-23 |
Decision Date | 1983-11-16 |