The following data is part of a premarket notification filed by Datex Division Instrumentarium Corp. with the FDA for As/3 Estpr Module.
| Device ID | K953175 |
| 510k Number | K953175 |
| Device Name: | AS/3 ESTPR MODULE |
| Classification | Monitor, St Segment With Alarm |
| Applicant | DATEX DIVISION INSTRUMENTARIUM CORP. 2 HIGHWOOD DR. Tewksbury, MA 01876 |
| Contact | Vincent Rausher |
| Correspondent | Vincent Rausher DATEX DIVISION INSTRUMENTARIUM CORP. 2 HIGHWOOD DR. Tewksbury, MA 01876 |
| Product Code | MLD |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-07 |
| Decision Date | 1997-02-06 |
| Summary: | summary |