Device Classification Name |
ventilator, non-continuous (respirator)
|
510(k) Number |
K183226 |
Device Name |
Care Orchestrator Essence |
Applicant |
Respironics Inc. |
1001 Murry Ridge Lane |
Murrysville,
PA
15642
|
|
Applicant Contact |
Michelle Brinker |
Correspondent |
Respironics Inc. |
1001 Murry Ridge Lane |
Murrysville,
PA
15642
|
|
Correspondent Contact |
Jennifer Rochardson |
Regulation Number | 868.5905
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 11/20/2018 |
Decision Date | 10/18/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|