The following data is part of a premarket notification filed by Datex Division Instrumentarium Corp. with the FDA for As/3 Light Monitor.
| Device ID | K961247 |
| 510k Number | K961247 |
| Device Name: | AS/3 LIGHT MONITOR |
| Classification | Electrocardiograph |
| Applicant | DATEX DIVISION INSTRUMENTARIUM CORP. 2 HIGHWOOD DR. Tewksbury, MA 01876 |
| Contact | Vincent Rauscher |
| Correspondent | Vincent Rauscher DATEX DIVISION INSTRUMENTARIUM CORP. 2 HIGHWOOD DR. Tewksbury, MA 01876 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-01 |
| Decision Date | 1996-10-23 |
| Summary: | summary |