FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SIMULATOR
K Number: K854265
·
Decision Mar 18, 1986
Classifications
1
FEI Numbers
115
Registration Numbers
116
Same Product Code
77
Applicant Total
2
Review Days
146
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Basic Information
- Device Name
- SIMULATOR
- K Number
- K854265
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2100
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Cygnus of South Florida, Inc.
- Date Received
- October 23, 1985
- Decision Date
- March 18, 1986
- Product Code
- JQP
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| JQP | Calculator/Data Processing Module, For Clinical Use | FDA class 1 | Clinical Chemistry |
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Other Clearances by Cygnus of South Florida, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K860854 | CRITICALC | Dec 8, 1986 | Substantially Equivalent |