The following data is part of a premarket notification filed by Datex Division Instrumentarium Corp. with the FDA for As/3 Memory Module, M0mem.
| Device ID | K945234 |
| 510k Number | K945234 |
| Device Name: | AS/3 MEMORY MODULE, M0MEM |
| Classification | Gas-machine, Anesthesia |
| Applicant | DATEX DIVISION INSTRUMENTARIUM CORP. P.O. BOX 446 SF-00101 Helsinki, Finland, FI |
| Contact | Antti Ritvos |
| Correspondent | Antti Ritvos DATEX DIVISION INSTRUMENTARIUM CORP. P.O. BOX 446 SF-00101 Helsinki, Finland, FI |
| Product Code | BSZ |
| CFR Regulation Number | 868.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-27 |
| Decision Date | 1995-01-27 |