FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GENIE
K Number: K961843
·
Decision Aug 22, 1996
Classifications
1
FEI Numbers
68
Registration Numbers
68
Same Product Code
73
Applicant Total
15
Review Days
101
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Basic Information
- Device Name
- GENIE
- K Number
- K961843
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4580
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Burton Medical Products Corp.
- Date Received
- May 13, 1996
- Decision Date
- August 22, 1996
- Product Code
- FSY
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| FSY | Light, Surgical, Ceiling Mounted | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Burton Medical Products Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K101537 | AIM 200, MAJOR SURGICAL LIGHT | Sep 30, 2010 | Substantially Equivalent |
| K042395 | OUTPATIENT III MINOR SURGERY LIGHT | Dec 1, 2004 | Substantially Equivalent |
| K000639 | VISIONARY 2000 | May 25, 2000 | Substantially Equivalent |
| K963682 | GENIE' SINGLE CEILING AND DOUBLE CEILING | Nov 13, 1996 | Substantially Equivalent |
| K935102 | SATURN LIGHT | Jun 27, 1994 | Substantially Equivalent |
| K942553 | GENESIS | Jun 23, 1994 | Substantially Equivalent |
| K936088 | WAVE FLUORESCENT MAGNIFIER | Apr 26, 1994 | Substantially Equivalent |
| K931645 | HALUX TASKLIGHT | Aug 20, 1993 | Substantially Equivalent |
| K901706 | LIGHT, HEAD, EXAMINATION | Jul 19, 1990 | Substantially Equivalent |
| K893807 | MODEL 0183010, PEARL MEDICAL EXAM LIGHT | Aug 15, 1989 | Substantially Equivalent |