The following data is part of a premarket notification filed by Philips Medizin Systeme Boeblingen Gmbh with the FDA for Intellispace Perinatal Rev.k.00.
| Device ID | K173941 |
| 510k Number | K173941 |
| Device Name: | IntelliSpace Perinatal Rev.K.00 |
| Classification | System, Monitoring, Perinatal |
| Applicant | Philips Medizin Systeme Boeblingen GmbH Hewlett-Packard-Str.-2 Boeblingen, DE 71034 |
| Contact | Christoph Krause |
| Correspondent | Christoph Krause Philips Medizin Systeme Boeblingen GmbH Hewlett-Packard-Str.-2 Boeblingen, DE 71034 |
| Product Code | HGM |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-26 |
| Decision Date | 2018-09-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838084483 | K173941 | 000 |