The following data is part of a premarket notification filed by Litton Medical Electronics with the FDA for Servomed Basic Bedside Unit Sms 108 W/.
| Device ID | K832026 |
| 510k Number | K832026 |
| Device Name: | SERVOMED BASIC BEDSIDE UNIT SMS 108 W/ |
| 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 | 1983-10-26 |