FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FLOCARE F
K Number: K903404
·
Decision Sep 25, 1990
Classifications
1
FEI Numbers
151
Registration Numbers
151
Same Product Code
87
Applicant Total
5
Review Days
56
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Basic Information
- Device Name
- FLOCARE F
- K Number
- K903404
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5975
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Flocare Medical
- Date Received
- July 31, 1990
- Decision Date
- September 25, 1990
- Product Code
- BZO
- 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 |
|---|---|---|---|
| BZO | Set, Tubing And Support, Ventilator (W Harness) | FDA class 1 | Anesthesiology |
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