ClariPulmo
System, Image Processing, Radiological
ClariPi Inc.
The following data is part of a premarket notification filed by Claripi Inc. with the FDA for Claripulmo.
Pre-market Notification Details
| Device ID | K203783 |
| 510k Number | K203783 |
| Device Name: | ClariPulmo |
| Classification | System, Image Processing, Radiological |
| Applicant | ClariPi Inc. 3F, 70-15, Ihwajang-gil Seoul, KR 03088 |
| Contact | Hyun-sook Park |
| Correspondent | Harry Park ClariPi Detroit Office 1645 Park Creek Ct. Rochester Hills Detroit, MI 48309 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-28 |
| Decision Date | 2022-04-06 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800046800020 | K203783 | 000 |
Trademark Results [ClariPulmo]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CLARIPULMO 88550920 not registered Live/Pending |
ClariPI Inc. 2019-07-30 |
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