The following data is part of a premarket notification filed by Invivo Research, Inc. with the FDA for Millennia 3500 Series Monitor With Anthesthetic Agent.
| Device ID | K974581 |
| 510k Number | K974581 |
| Device Name: | MILLENNIA 3500 SERIES MONITOR WITH ANTHESTHETIC AGENT |
| Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| Applicant | INVIVO RESEARCH, INC. 12601 RESEARCH PKWY. Orlando, FL 32826 |
| Contact | Francis Casey |
| Correspondent | Francis Casey INVIVO RESEARCH, INC. 12601 RESEARCH PKWY. Orlando, FL 32826 |
| Product Code | DRT |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-08 |
| Decision Date | 1998-10-28 |
| Summary: | summary |