FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DEUCE
K Number: K943244
·
Decision Sep 11, 1995
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
23
Applicant Total
2
Review Days
432
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Basic Information
- Device Name
- DEUCE
- K Number
- K943244
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.3725
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Apt Technology, Inc.
- Date Received
- July 6, 1994
- Decision Date
- September 11, 1995
- Product Code
- IQA
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- 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 |
|---|---|---|---|
| IQA | System, Environmental Control, Powered | FDA class 2 | Physical Medicine |
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Other Clearances by Apt Technology, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K953937 | LIAISON COMPUTER ACCESS & ENVIRONMENTAL CONTROL SYSTEM | Oct 31, 1995 | Substantially Equivalent |