The following data is part of a premarket notification filed by Philips Medical Systems with the FDA for M3290a Intellivue Information Center Software, Release 1.00.
| Device ID | K081983 |
| 510k Number | K081983 |
| Device Name: | M3290A INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE 1.00 |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | PHILIPS MEDICAL SYSTEMS 3000 MINUTEMEN RD. Andover, MA 01810 -1099 |
| Contact | Claire Arakaki |
| Correspondent | Claire Arakaki PHILIPS MEDICAL SYSTEMS 3000 MINUTEMEN RD. Andover, MA 01810 -1099 |
| Product Code | MHX |
| Subsequent Product Code | DSH |
| Subsequent Product Code | DSI |
| Subsequent Product Code | MLD |
| Subsequent Product Code | MSX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-11 |
| Decision Date | 2008-08-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838083400 | K081983 | 000 |
| 00884838082694 | K081983 | 000 |
| 00884838082687 | K081983 | 000 |
| 00884838082670 | K081983 | 000 |
| 00884838082663 | K081983 | 000 |
| 00884838082656 | K081983 | 000 |
| 00884838082649 | K081983 | 000 |
| 00884838082632 | K081983 | 000 |
| 00884838082274 | K081983 | 000 |