FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PULMONARY TEST SYSTEM FUDAC-30
K Number: K852307
·
Decision Jul 5, 1985
Classifications
1
FEI Numbers
97
Registration Numbers
97
Same Product Code
226
Applicant Total
17
Review Days
37
Basic Information
- Device Name
- PULMONARY TEST SYSTEM FUDAC-30
- K Number
- K852307
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1840
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- FUTUREMED DIV. OF FUTURE IMPEX CORP.
- Date Received
- May 29, 1985
- Decision Date
- July 5, 1985
- Product Code
- BZG
- 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 |
|---|---|---|---|
| BZG | Spirometer, Diagnostic | FDA class 2 | Anesthesiology |
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