The following data is part of a premarket notification filed by Pie Medical Imaging Bv with the FDA for Caas Workstation.
Device ID | K180019 |
510k Number | K180019 |
Device Name: | CAAS Workstation |
Classification | System, X-ray, Angiographic |
Applicant | Pie Medical Imaging BV Philipsweg 1 Maastricht, NL 6227 Aj |
Contact | Annemiek Bouts |
Correspondent | Annemiek Bouts Pie Medical Imaging BV Philipsweg 1 Maastricht, NL 6227 Aj |
Product Code | IZI |
CFR Regulation Number | 892.1600 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-01-02 |
Decision Date | 2018-05-03 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
08056304454058 | K180019 | 000 |
08056304454003 | K180019 | 000 |
08056304454331 | K180019 | 000 |
08056304454461 | K180019 | 000 |
08056304455314 | K180019 | 000 |