DuraDiagnost
System, X-ray, Stationary
Philips Healthcare (Suzhou) Co., Ltd.
The following data is part of a premarket notification filed by Philips Healthcare (suzhou) Co., Ltd. with the FDA for Duradiagnost.
Pre-market Notification Details
| Device ID | K201640 |
| 510k Number | K201640 |
| Device Name: | DuraDiagnost |
| Classification | System, X-ray, Stationary |
| Applicant | Philips Healthcare (Suzhou) Co., Ltd. No. 258, Zhong Yuan Road, Suzhou Industrial Park Suzhou, CN 215024 |
| Contact | Mary Zhu |
| Correspondent | Mary Zhu Philips Healthcare (Suzhou) Co., Ltd. No. 258, Zhong Yuan Road, Suzhou Industrial Park Suzhou, CN 215024 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-16 |
| Decision Date | 2020-07-09 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838095205 | K201640 | 000 |
Trademark Results [DuraDiagnost]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DURADIAGNOST 79114722 4441771 Live/Registered |
Koninklijke Philips N.V. 2012-05-31 |
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