The following data is part of a premarket notification filed by Philips Medical Systems Nethrlands Bv with the FDA for Philips Intellispace Cardiovascular.
| Device ID | K153022 |
| 510k Number | K153022 |
| Device Name: | Philips IntelliSpace Cardiovascular |
| Classification | System, Image Processing, Radiological |
| Applicant | PHILIPS MEDICAL SYSTEMS NETHRLANDS BV VEENPLUIS 4-6 Best, NL 5684 Pc |
| Contact | Dave J.w. Bierhuizen |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2015-10-15 |
| Decision Date | 2015-11-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838091429 | K153022 | 000 |
| 00884838115378 | K153022 | 000 |
| 00884838106970 | K153022 | 000 |
| 00884838095250 | K153022 | 000 |
| 00884838093072 | K153022 | 000 |
| 00884838075214 | K153022 | 000 |
| 00884838085220 | K153022 | 000 |
| 00884838085770 | K153022 | 000 |
| 00884838087460 | K153022 | 000 |
| 00884838100107 | K153022 | 000 |