The following data is part of a premarket notification filed by Litton Medical Electronics with the FDA for Servomed Pulse Amplifier Module-206-.
| Device ID | K840523 |
| 510k Number | K840523 |
| Device Name: | SERVOMED PULSE AMPLIFIER MODULE-206- |
| Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| Applicant | LITTON MEDICAL ELECTRONICS 777 NICHOLAS BLVD. Elk Grove Village, IL 60007 |
| Contact | Casarsa |
| Correspondent | Casarsa LITTON MEDICAL ELECTRONICS 777 NICHOLAS BLVD. Elk Grove Village, IL 60007 |
| Product Code | DRT |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-02-07 |
| Decision Date | 1984-10-29 |