The following data is part of a premarket notification filed by Datex Division Instrumentarium Corp. with the FDA for Datex As/3 Patient Monitor.
| Device ID | K933156 |
| 510k Number | K933156 |
| Device Name: | DATEX AS/3 PATIENT MONITOR |
| Classification | Electrocardiograph |
| Applicant | DATEX DIVISION INSTRUMENTARIUM CORP. TEOLLISUUSKATU 27 Helsinki, FI Sf-00101 |
| Contact | Hannu Ahjapalo |
| Correspondent | Hannu Ahjapalo DATEX DIVISION INSTRUMENTARIUM CORP. TEOLLISUUSKATU 27 Helsinki, FI Sf-00101 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-29 |
| Decision Date | 1994-12-30 |