The following data is part of a premarket notification filed by Datex Division Instrumentarium Corp. with the FDA for Ngm Estp Module.
| Device ID | K911646 |
| 510k Number | K911646 |
| Device Name: | NGM ESTP MODULE |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| 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 | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-15 |
| Decision Date | 1992-02-21 |