The following data is part of a premarket notification filed by Datex Division Instrumentarium Corp. with the FDA for As/3 Tm Network.
| Device ID | K933284 |
| 510k Number | K933284 |
| Device Name: | AS/3 TM NETWORK |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | DATEX DIVISION INSTRUMENTARIUM CORP. 27 TEOLLISUUSKATU Helsinki, FI |
| Contact | Hannu Ahjopalo |
| Correspondent | Hannu Ahjopalo DATEX DIVISION INSTRUMENTARIUM CORP. 27 TEOLLISUUSKATU Helsinki, FI |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-06 |
| Decision Date | 1994-07-11 |