The following data is part of a premarket notification filed by Philips Healthcare (suzhou) Co., Ltd. with the FDA for Duradiagnost.
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 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00884838095205 | K201640 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
DURADIAGNOST 79114722 4441771 Live/Registered |
Koninklijke Philips N.V. 2012-05-31 |