FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Masimo Acoustic Respiration Sensors, infant and neonate
K Number: K173976
·
Decision Sep 5, 2018
Classifications
1
FEI Numbers
109
Registration Numbers
109
Same Product Code
174
Applicant Total
85
Review Days
250
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Basic Information
- Device Name
- Masimo Acoustic Respiration Sensors, infant and neonate
- K Number
- K173976
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 868.2375
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Masimo Corporation
- Date Received
- December 29, 2017
- Decision Date
- September 5, 2018
- 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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