The following data is part of a premarket notification filed by Getinge International, Inc. with the FDA for Decomat 228.
| Device ID | K920406 |
| 510k Number | K920406 |
| Device Name: | DECOMAT 228 |
| Classification | Cleaners, Medical Devices |
| Applicant | GETINGE INTERNATIONAL, INC. 1100 TOWBIN AVE. Lakewood, NJ 08701 |
| Contact | Paul Rodriguez |
| Correspondent | Paul Rodriguez GETINGE INTERNATIONAL, INC. 1100 TOWBIN AVE. Lakewood, NJ 08701 |
| Product Code | MDZ |
| CFR Regulation Number | 880.6992 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-01-31 |
| Decision Date | 1994-04-05 |