The following data is part of a premarket notification filed by Hill-rom Services Pte Ltd with the FDA for Maximus System.
| Device ID | K200988 |
| 510k Number | K200988 |
| Device Name: | Maximus System |
| Classification | Device, Positive Pressure Breathing, Intermittent |
| Applicant | Hill-Rom Services Pte Ltd 1 Yishun Ave 7 Singapore, SG 768923 |
| Contact | Alvin Tan |
| Correspondent | Paul Dryden Hill-Rom Services Pte Ltd 1 Yishun Ave 7 Singapore, SG 768923 |
| Product Code | NHJ |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-15 |
| Decision Date | 2020-05-26 |
| Summary: | summary |