FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
GALEMED PEAK FLOW METER, MODELS 3751/3752
K Number: K022124
·
Decision Apr 3, 2003
Classifications
1
FEI Numbers
41
Registration Numbers
41
Same Product Code
79
Applicant Total
7
Review Days
276
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Basic Information
- Device Name
- GALEMED PEAK FLOW METER, MODELS 3751/3752
- K Number
- K022124
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1860
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Galemed Corp.
- Date Received
- July 1, 2002
- Decision Date
- April 3, 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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| K082092 | DISPO-BAG MANUAL RESUSCITATOR, DISPOSABLE ADJUSTABLE PEEP VALVE, DISPOSABLE FIXED PEEP VALVE | Oct 15, 2008 | Substantially Equivalent |
| K072755 | GALEMED CPAP MASK | Nov 16, 2007 | Substantially Equivalent |
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