FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
The C100 Contactless Breathing Monitor
K Number: K200445
·
Decision Jun 24, 2020
Classifications
1
FEI Numbers
109
Registration Numbers
109
Same Product Code
174
Applicant Total
2
Review Days
121
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Basic Information
- Device Name
- The C100 Contactless Breathing Monitor
- K Number
- K200445
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.2375
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Circadia Technologies, Ltd.
- Date Received
- February 24, 2020
- Decision Date
- June 24, 2020
- Product Code
- BZQ
- 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 |
|---|---|---|---|
| BZQ | Monitor, Breathing Frequency | FDA class 2 | Anesthesiology |
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Other Clearances by Circadia Technologies, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K234003 | The Circadia C200 System | May 30, 2024 | Substantially Equivalent |