The following data is part of a premarket notification filed by Hill-rom Services Pte Ltd with the FDA for Maximus System.
| Device ID | K192143 |
| 510k Number | K192143 |
| Device Name: | Maximus System |
| Classification | Device, Positive Pressure Breathing, Intermittent |
| Applicant | Hill-Rom Services Pte Ltd 1 Yishun Ave 7 Singapore, SG |
| Contact | Alvin Tan |
| Correspondent | Paul Dryden Hill-Rom Services Pte Ltd 1 Yishun Ave 7 Singapore, SG |
| Product Code | NHJ |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-08 |
| Decision Date | 2020-02-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887761984578 | K192143 | 000 |
| 00887761985018 | K192143 | 000 |
| 00887761984530 | K192143 | 000 |
| 00887761984608 | K192143 | 000 |
| 00887761984615 | K192143 | 000 |
| 00887761985025 | K192143 | 000 |
| 10887761981499 | K192143 | 000 |
| 00887761984547 | K192143 | 000 |
| 00887761984585 | K192143 | 000 |
| 00887761984592 | K192143 | 000 |
| 00887761984622 | K192143 | 000 |
| 00887761995062 | K192143 | 000 |
| 00887761984554 | K192143 | 000 |
| 00887761981690 | K192143 | 000 |