The following data is part of a premarket notification filed by Maquet Gmbh with the FDA for Getinge Gss610n Series Steam Sterilizer.
| Device ID | K201927 |
| 510k Number | K201927 |
| Device Name: | Getinge GSS610N Series Steam Sterilizer |
| Classification | Sterilizer, Steam |
| Applicant | Maquet GmbH Kehler Strasse 31 Rastatt, DE 76437 |
| Contact | Holger Ullrich |
| Correspondent | Mark Smith Getinge 45 Barbour Pond Road Wayne, NY 07470 |
| Product Code | FLE |
| CFR Regulation Number | 880.6880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-10 |
| Decision Date | 2021-03-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04053275000080 | K201927 | 000 |
| 04053275000073 | K201927 | 000 |
| 04053275000066 | K201927 | 000 |