Device Classification Name |
ventilator, non-continuous (respirator)
|
510(k) Number |
K200565 |
Device Name |
Galapogos |
Applicant |
ResMed Corp |
9001 Spectrum Center Blvd |
San Diego,
CA
92123
|
|
Applicant Contact |
Rose Malonzo |
Correspondent |
ResMed Corp |
9001 Spectrum Center Blvd |
San Diego,
CA
92123
|
|
Correspondent Contact |
Rose Malonzo |
Regulation Number | 868.5905
|
Classification Product Code |
|
Date Received | 03/04/2020 |
Decision Date | 01/17/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|