The following data is part of a premarket notification filed by Claritas Healthtech Pte Ltd with the FDA for Claritas Ipet.
Device ID | K213140 |
510k Number | K213140 |
Device Name: | Claritas IPET |
Classification | System, Image Processing, Radiological |
Applicant | Claritas HealthTech Pte Ltd 20A Tanjong Pagar Road Singapore, SG 088443 |
Contact | Devika Dutt |
Correspondent | Devika Dutt Claritas HealthTech Pte Ltd 20A Tanjong Pagar Road Singapore, SG 088443 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-09-27 |
Decision Date | 2021-12-22 |