FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COMPUSPEAK
K Number: K941566
·
Decision Jun 30, 1995
Classifications
1
FEI Numbers
599
Registration Numbers
599
Same Product Code
2271
Applicant Total
26
Review Days
455
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Basic Information
- Device Name
- COMPUSPEAK
- K Number
- K941566
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hogan & Hartson
- Date Received
- April 1, 1994
- Decision Date
- June 30, 1995
- Product Code
- LLZ
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | FDA class 2 | Radiology |
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| K942389 | TROCARS, TROCAR SLEEVES AND REDUCTION SLEEVES | Feb 16, 1996 | Substantially Equivalent |
| K946217 | CARDIOLIPIN M EIA TEST SYSTEM | Jan 24, 1996 | Substantially Equivalent |
| K946216 | CARDIOLIPIN A EIA TEST SYSTEM | Jan 24, 1996 | Substantially Equivalent |
| K946215 | CARDIOLIPIN G EIA TEST SYSTEM | Jan 24, 1996 | Substantially Equivalent |
| K946186 | CHAL-2500 | Aug 14, 1995 | Substantially Equivalent for Some Indications |
| K950110 | MARDX MITOCHONDRIA EIA TEST SYSTEM | May 15, 1995 | Substantially Equivalent |