FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO TRUPEAK PEAK FLOW METER
K Number: K031514
·
Decision May 23, 2003
Classifications
1
FEI Numbers
41
Registration Numbers
41
Same Product Code
79
Applicant Total
33
Review Days
9
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Basic Information
- Device Name
- MODIFICATION TO TRUPEAK PEAK FLOW METER
- K Number
- K031514
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 868.1860
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Monaghan Medical Corp.
- Date Received
- May 14, 2003
- Decision Date
- May 23, 2003
- 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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| K964130 | AEROGEAR ASTHMA ACTION KIT | Jan 10, 1997 | Substantially Equivalent |
| K963089 | TRUZONE PEAK FLOW METER | Nov 6, 1996 | Substantially Equivalent |
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| K955234 | TRUPEAK PEAK FLOW METER | Mar 18, 1996 | Substantially Equivalent |
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