FDA 510(k) K223144, Galaxy System, by Noah Medical Corp.
FDA 510(k) K223144, Galaxy System, by Noah Medical Corp.
| 510(k) Number | K223144 |
| Device Classification Name | Bronchoscope (Flexible Or Rigid) |
| Device Name | Galaxy System |
| Applicant | Noah Medical Corp. 1501 Industrial Rd. San Carlos, CA 94070 |
| Regulation Number | 874.468 |
| Classification Product Code | EOQ |
| Date Received | 10/04/2022 |
| Decision Date | 03/01/2023 |
| Decision | Substantially Equivalent (SESE) |
| Regulation Medical Specialty | Ear Nose & Throat |
| 510k Review Panel | Ear Nose & Throat |
| Type | Traditional |
| Reviewed by Third Party | No |
| Combination Product | No |
| Total Pages | 7389 |
| Redacted Pages | 6930 |
| Unredacted Pages | 459 |
Couldn't load pickup availability
PLEASE NOTE: Most 510(k)s obtained through FOIA are heavily redacted, often omitting sections related to testing, software, manufacturing, and other technical data. Please be sure to review the total pages, redacted pages, and content pages listed in the description to get a sense of how much of the document is redacted. As the FDA FOIA office explains: “We HEAVILY REDACT the majority of the following portions of 510(k) filings: testing data, technical data, lab reports, manufacturing information, vendor information, substantive discussions regarding deficiencies or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.” If you’d like more details about a specific document before purchasing, please contact us at info@foiadocs.com.
View full details