PhoeniX

System, X-ray, Mobile

Sedecal, SA.

The following data is part of a premarket notification filed by Sedecal, Sa. with the FDA for Phoenix.

Pre-market Notification Details

• Device ID: K192011
• 510k Number: K192011
• Device Name: PhoeniX
• Classification: System, X-ray, Mobile
• Applicant: Sedecal, SA. C/Pelaya, 9 -13 Pol. Ind. Rio De Janeiro Algete, ES 28110
• Contact: Mª Luisa Gomez De Aguero
• Correspondent: Daniel Kamm; Kamm & Associates 8870 Ravello Ct Naples, FL 34114
• Product Code: IZL
• CFR Regulation Number: 892.1720 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Abbreviated
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-07-29
• Decision Date: 2019-09-25
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
08436046002494	K192011	000
08436046002487	K192011	000
08436046002470	K192011	000
08436046002364	K192011	000