Phototherapy System
K-Number: K190938 · 2019-06-26
Device Summary
Frequently Asked Questions
What is the Phototherapy System?
Phototherapy System is a medical device that received FDA 510(k) clearance on 2019-06-26. The listed applicant is Shanghai Apolo Medical Technology Co., Ltd.. The 510(k) number is K190938.
When did Phototherapy System receive FDA 510(k) clearance?
Phototherapy System received FDA 510(k) clearance on 2019-06-26, under 510(k) number K190938.
Who is the listed applicant for Phototherapy System?
The FDA 510(k) record lists Shanghai Apolo Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Phototherapy System?
The FDA product code for Phototherapy System is GEX. This falls under the Gastroenterology category.
Other records listing Shanghai Apolo Medical Technology Co., Ltd. as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: GEX)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.