Blue Sky Bio Aligner
K-Number: K180107 · 2018-02-09
Device Summary
Frequently Asked Questions
What is the Blue Sky Bio Aligner?
Blue Sky Bio Aligner is a medical device that received FDA 510(k) clearance on 2018-02-09. The listed applicant is Blue Sky Bio, LLC. The 510(k) number is K180107.
When did Blue Sky Bio Aligner receive FDA 510(k) clearance?
Blue Sky Bio Aligner received FDA 510(k) clearance on 2018-02-09, under 510(k) number K180107.
Who is the listed applicant for Blue Sky Bio Aligner?
The FDA 510(k) record lists Blue Sky Bio, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Blue Sky Bio Aligner?
The FDA product code for Blue Sky Bio Aligner is NXC.
Other records listing Blue Sky Bio, LLC 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: NXC)
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.