FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PEAK FLOW METER
K Number: K770580
·
Decision Aug 4, 1977
Classifications
1
FEI Numbers
41
Registration Numbers
41
Same Product Code
79
Applicant Total
3
Review Days
129
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Basic Information
- Device Name
- PEAK FLOW METER
- K Number
- K770580
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1860
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Projects IN Health
- Date Received
- March 28, 1977
- Decision Date
- August 4, 1977
- 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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