The following data is part of a premarket notification filed by Datex-engstrom, Inc. with the FDA for As/3 Anaesthesia Delivery Unit (as/3 Adu).
| Device ID | K973985 |
| 510k Number | K973985 |
| Device Name: | AS/3 ANAESTHESIA DELIVERY UNIT (AS/3 ADU) |
| Classification | Gas-machine, Anesthesia |
| Applicant | DATEX-ENGSTROM, INC. 2 HIGHWOOD DR. Tewksbury, MA 01876 |
| Contact | Joel Kent |
| Correspondent | Joel Kent DATEX-ENGSTROM, INC. 2 HIGHWOOD DR. Tewksbury, MA 01876 |
| Product Code | BSZ |
| CFR Regulation Number | 868.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-20 |
| Decision Date | 1998-10-30 |