FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ASTECH HOME PEAK FLOW METER
K Number: K915060
·
Decision Sep 11, 1992
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
78
Applicant Total
6
Review Days
308
Basic Information
- Device Name
- ASTECH HOME PEAK FLOW METER
- K Number
- K915060
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1860
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- BIOTRINE CORP.
- Date Received
- November 8, 1991
- Decision Date
- September 11, 1992
- 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 BIOTRINE CORP.
| K Number | Device Name | ||
|---|---|---|---|
| K883704 | MULTIICHALLENGE NEBULIZER SYSTEM | Nov 28, 1988 | Substantially Equivalent |
| K863134 | MULTISPIRO SA/100 | Dec 15, 1986 | Substantially Equivalent |
| K844226 | B-1000 | Nov 20, 1984 | Substantially Equivalent |
| K813414 | PEAK FLOW MONITOR | Dec 31, 1981 | Substantially Equivalent |
| K812825 | FLO-COR I | Oct 26, 1981 | Substantially Equivalent |