FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FLO-COR I
K Number: K812825
·
Decision Oct 26, 1981
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
7
Applicant Total
6
Review Days
18
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Basic Information
- Device Name
- FLO-COR I
- K Number
- K812825
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.2550
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Biotrine Corp.
- Date Received
- October 8, 1981
- Decision Date
- October 26, 1981
- Product Code
- JAX
- 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 |
|---|---|---|---|
| JAX | Pneumotachometer | FDA class 2 | Anesthesiology |
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Other Clearances by Biotrine Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K915060 | ASTECH HOME PEAK FLOW METER | Sep 11, 1992 | Substantially Equivalent |
| 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 |