FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EMMA Capnograph
K Number: K201590
·
Decision Mar 29, 2021
Classifications
1
FEI Numbers
217
Registration Numbers
217
Same Product Code
304
Applicant Total
85
Review Days
290
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Basic Information
- Device Name
- EMMA Capnograph
- K Number
- K201590
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 868.1400
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Masimo Corporation
- Date Received
- June 12, 2020
- Decision Date
- March 29, 2021
- Product Code
- CCK
- 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 |
|---|---|---|---|
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | FDA class 2 | Anesthesiology |
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| K250757 | Radius VSM and Accessories | May 29, 2025 | Substantially Equivalent |
| K243305 | Masimo W1 | Apr 3, 2025 | Substantially Equivalent |
| K240229 | Masimo W1 | Aug 8, 2024 | Substantially Equivalent |
| K234021 | Masimo Stork | May 3, 2024 | Substantially Equivalent |
| K214115 | MightySat -OTC | Jan 31, 2024 | Substantially Equivalent |
| K223721 | Masimo Stork | Dec 15, 2023 | Substantially Equivalent |
| K232512 | Masimo W1 | Nov 17, 2023 | Substantially Equivalent |
| DEN200076 | ORi | Oct 12, 2023 | Unknown |