FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Care Orchestrator Essence
K Number: K183226
·
Decision Oct 18, 2019
Classifications
1
FEI Numbers
118
Registration Numbers
118
Same Product Code
459
Applicant Total
172
Review Days
332
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Care Orchestrator Essence
- K Number
- K183226
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5905
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Respironics, Inc.
- Date Received
- November 20, 2018
- Decision Date
- October 18, 2019
- Product Code
- BZD
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| BZD | Ventilator, Non-Continuous (Respirator) | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BZD), ordered by most recent decision date.
Orion
FDA 510(k)
FDA Class 2
·Anesthesiology
ResScan Essentials
FDA 510(k)
FDA Class 2
·Anesthesiology
Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face Mask
FDA 510(k)
FDA Class 2
·Anesthesiology
F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)
FDA 510(k)
FDA Class 2
·Anesthesiology
MySleepDash
FDA 510(k)
FDA Class 2
·Anesthesiology
Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask
FDA 510(k)
FDA Class 2
·Anesthesiology
Other Clearances by Respironics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K243394 | AF531 Oro-Nasal SE Face Mask | Dec 30, 2024 | Substantially Equivalent |
| K231313 | Therapy Mask 3100 NC/SP | Jul 28, 2023 | Substantially Equivalent |
| K210844 | DreamWear Silicone Pillows Mask | Aug 24, 2021 | Substantially Equivalent |
| K210386 | Magneto Nasal Mask | Jul 12, 2021 | Substantially Equivalent |
| K202142 | Sleepware G3 | Oct 29, 2020 | Substantially Equivalent |
| K201439 | Ventilator, Non-continuous (Respirator) | Sep 25, 2020 | Substantially Equivalent |
| K200480 | DreamStation 2 System, DreamStation 2 Advanced System | Jul 10, 2020 | Substantially Equivalent |
| K183625 | SomnaPatch | Oct 18, 2019 | Substantially Equivalent |
| K181166 | Trilogy Evo | Jul 18, 2019 | Substantially Equivalent |
| K181170 | Trilogy Evo Universal | Jul 18, 2019 | Substantially Equivalent |