FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SKYTRON MODEL 1100 AND MODEL 142
K Number: K900290
·
Decision Feb 20, 1990
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
9
Applicant Total
19
Review Days
29
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Basic Information
- Device Name
- SKYTRON MODEL 1100 AND MODEL 142
- K Number
- K900290
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4960
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Skytron, Div. the Kmw Group, Inc.
- Date Received
- January 22, 1990
- Decision Date
- February 20, 1990
- Product Code
- JEA
- 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 |
|---|---|---|---|
| JEA | Table, Surgical With Orthopedic Accessories, Ac-Powered | FDA class 1 | General, Plastic Surgery |
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Other Clearances by Skytron, Div. the Kmw Group, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K071698 | AURORA LED SERIES SURGICAL LIGHTS | Jul 6, 2007 | Substantially Equivalent |
| K021585 | STELLAR SERIES SURGICAL LIGHTS WITH HERMES | Nov 13, 2002 | Substantially Equivalent |
| K002463 | STELLAR | Nov 8, 2000 | Substantially Equivalent |
| K992090 | MILLENNIUM GOLD | Sep 8, 1999 | Substantially Equivalent |
| K950192 | SKYTRON SKYBOOM SERIES | Apr 3, 1995 | Substantially Equivalent |
| K940616 | SKYTRON ELITE 3500 TABLE | Jun 13, 1994 | Substantially Equivalent |
| K933564 | SKYTRON EXAM LIGHT | Feb 10, 1994 | Substantially Equivalent |
| K926045 | SKYTRON LIFE ISLAND 21 | Jul 27, 1993 | Substantially Equivalent |
| K915285 | SKYTRON INFINITY SERIES SURGICAL LIGHTS | Feb 20, 1992 | Substantially Equivalent |
| K900472 | SKYTRON MODEL 860 AND 800 COMP. SURGITA NEURO EQUI | Sep 4, 1990 | Substantially Equivalent |