FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
MSA100 PEAK FLOW METER
K Number: K133975
·
Decision Oct 3, 2014
Classifications
1
FEI Numbers
41
Registration Numbers
41
Same Product Code
79
Applicant Total
2
Review Days
281
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Basic Information
- Device Name
- MSA100 PEAK FLOW METER
- K Number
- K133975
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1860
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Beijing M&B Electronic Instruments Co., Ltd.
- Date Received
- December 26, 2013
- Decision Date
- October 3, 2014
- Product Code
- BZH
- 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 |
|---|---|---|---|
| BZH | Meter, Peak Flow, Spirometry | FDA class 2 | Anesthesiology |
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Other Clearances by Beijing M&B Electronic Instruments Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K170281 | MSA100BT Peak Flow Meter | Oct 6, 2017 | Substantially Equivalent |