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
08436046003668	K192011	000
08436046003675	K192011	000
08436046003682	K192011	000
08436046003699	K192011	000
08436046003705	K192011	000
08436046003712	K192011	000
08436046003729	K192011	000
08436046002364	K192011	000
08436046002470	K192011	000
08436046002487	K192011	000
08436046003651	K192011	000