FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SKYTRON MODEL 610-2
K Number: K870045
·
Decision Feb 4, 1987
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
27
Applicant Total
19
Review Days
30
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Basic Information
- Device Name
- SKYTRON MODEL 610-2
- K Number
- K870045
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5160
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Skytron, Div. the Kmw Group, Inc.
- Date Received
- January 5, 1987
- Decision Date
- February 4, 1987
- Product Code
- INX
- 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 |
|---|---|---|---|
| INX | Bed, Air Fluidized | FDA class 2 | Physical Medicine |
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Other Clearances by Skytron, Div. the Kmw Group, Inc.
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|---|---|---|---|
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| 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 |