The following data is part of a premarket notification filed by Datex-engstrom, Inc. with the FDA for Datex-engstrom Light Monitor Models F-lm1, F-lmp1.
| Device ID | K981378 |
| 510k Number | K981378 |
| Device Name: | DATEX-ENGSTROM LIGHT MONITOR MODELS F-LM1, F-LMP1 |
| Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| Applicant | DATEX-ENGSTROM, INC. 3 HIGHWOOD DR. Tewksbury, MA 01876 |
| Contact | Joel C Kent |
| Correspondent | Joel C Kent DATEX-ENGSTROM, INC. 3 HIGHWOOD DR. Tewksbury, MA 01876 |
| Product Code | DRT |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-16 |
| Decision Date | 1998-11-03 |