The following data is part of a premarket notification filed by Philips Medizin Systeme Böblingen Gmbh with the FDA for Patient Information Center Ix.
| Device ID | K211900 |
| 510k Number | K211900 |
| Device Name: | Patient Information Center IX |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | Philips Medizin Systeme Böblingen GmbH Hewlett-Packard Str.2 Böblingen, DE 71034 |
| Contact | Peng Cui |
| Correspondent | Peng Cui Philips Medizin Systeme Böblingen GmbH Hewlett-Packard Str.2 Böblingen, DE 71034 |
| Product Code | MHX |
| Subsequent Product Code | DSH |
| Subsequent Product Code | DSI |
| Subsequent Product Code | MLD |
| Subsequent Product Code | MSX |
| Subsequent Product Code | OUG |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-21 |
| Decision Date | 2022-03-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838104594 | K211900 | 000 |
| 00884838112070 | K211900 | 000 |
| 00884838121782 | K211900 | 000 |
| 00884838122772 | K211900 | 000 |