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 |