FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ERS SYSTEM
K Number: K863286
·
Decision Oct 27, 1986
Classifications
1
FEI Numbers
63
Registration Numbers
63
Same Product Code
54
Applicant Total
254
Review Days
63
Basic Information
- Device Name
- ERS SYSTEM
- K Number
- K863286
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.2010
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- GENERAL ELECTRIC CO.
- Date Received
- August 25, 1986
- Decision Date
- October 27, 1986
- Product Code
- LMB
- 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 |
|---|---|---|---|
| LMB | Device, Digital Image Storage, Radiological | FDA class 1 | Radiology |
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|---|---|---|---|
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| K063006 | GE LOGIQ WORKS | Nov 2, 2006 | Substantially Equivalent |
| K061682 | GE VOLUSON E8 ULTRASOUND SYSTEM | Jul 12, 2006 | Substantially Equivalent |