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 |
00884838100107 | 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 |
00884838122000 | K153022 | 000 |