1
/
of
0
FDA & Noah Medical – Galaxy System Correspondence (Post-K223144)
FDA & Noah Medical – Galaxy System Correspondence (Post-K223144)
Regular price
$69.00 USD
Regular price
Sale price
$69.00 USD
Unit price
/
per
510(K) Number: K223144
Device Name: Galaxy System
Manufacturer: Noah Medical Corp.
Device Classification Name: Bronchoscope (Flexible Or Rigid)
Regulation Number: 874.4680
Classification Product Code: EOQ
Date Received: 10/04/2022
Decision Date: 03/01/2023
Regulation Medical Specialty: Ear Nose & Throat
Request Contents: Correspondence and communications between FDA and Noah Medical Corporation related to the Galaxy System, including submissions after 510(k) clearance K223144.
Device Name: Galaxy System
Manufacturer: Noah Medical Corp.
Device Classification Name: Bronchoscope (Flexible Or Rigid)
Regulation Number: 874.4680
Classification Product Code: EOQ
Date Received: 10/04/2022
Decision Date: 03/01/2023
Regulation Medical Specialty: Ear Nose & Throat
Request Contents: Correspondence and communications between FDA and Noah Medical Corporation related to the Galaxy System, including submissions after 510(k) clearance K223144.
Couldn't load pickup availability
- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
View full details