FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
Besmed Peak Flow Meter
K Number: K172804
·
Decision Jan 11, 2018
Classifications
1
FEI Numbers
41
Registration Numbers
41
Same Product Code
79
Applicant Total
10
Review Days
115
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Basic Information
- Device Name
- Besmed Peak Flow Meter
- K Number
- K172804
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1860
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Besmed Health Business Corp
- Date Received
- September 18, 2017
- Decision Date
- January 11, 2018
- 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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|---|---|---|---|
| K241339 | Besmed Bacterial Filter and HMEF | Nov 14, 2024 | Substantially Equivalent |
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| K150591 | Besmed Reusable Jet Nebulizer | Jun 30, 2015 | Substantially Equivalent |
| K143150 | CO2 monitoring line with and without in-line filter | Feb 5, 2015 | Substantially Equivalent |
| K140370 | DISPOSABLE PRESSURE MANOMETER | Jun 19, 2014 | Substantially Equivalent |
| K133873 | TRIBALL INCENTIVE SPIROMETER | Apr 4, 2014 | Substantially Equivalent |
| K091272 | BESMED JET NEBULIZER BOTTLE SET | Nov 10, 2009 | Substantially Equivalent |
| K031374 | BESMED VARIOUS MODELS OF TENS, BE-550/BE-660 | Nov 28, 2003 | Substantially Equivalent |
| K031375 | BESMED VARIOUS MODELS OF POWERED MUSCLE STIMULATOR, BE-560/BE-580 | Nov 20, 2003 | Substantially Equivalent |