The following data is part of a premarket notification filed by Philips Healthcare with the FDA for Percunav System.
Device ID | K132087 |
510k Number | K132087 |
Device Name: | PERCUNAV SYSTEM |
Classification | System, X-ray, Tomography, Computed |
Applicant | PHILIPS HEALTHCARE 49 SPADINA AVENUE #310 Toronto, CA M5v 2j1 |
Contact | Dave Szczupakowski |
Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
Product Code | JAK |
Subsequent Product Code | IYO |
Subsequent Product Code | LLZ |
CFR Regulation Number | 892.1750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2013-07-05 |
Decision Date | 2013-07-24 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00884838083059 | K132087 | 000 |
00884838068629 | K132087 | 000 |
00884838068636 | K132087 | 000 |
00884838068643 | K132087 | 000 |
00884838081239 | K132087 | 000 |
00884838081253 | K132087 | 000 |
00884838082960 | K132087 | 000 |
00884838082984 | K132087 | 000 |
00884838082991 | K132087 | 000 |
00884838083004 | K132087 | 000 |
00884838083011 | K132087 | 000 |
00884838083028 | K132087 | 000 |
00884838083035 | K132087 | 000 |
00884838083042 | K132087 | 000 |
00884838068605 | K132087 | 000 |