FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SKYTRON MODEL 860 AND 800 COMP. SURGITA NEURO EQUI
K Number: K900472
·
Decision Sep 4, 1990
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
3
Applicant Total
19
Review Days
216
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Basic Information
- Device Name
- SKYTRON MODEL 860 AND 800 COMP. SURGITA NEURO EQUI
- K Number
- K900472
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 882.4125
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Skytron, Div. the Kmw Group, Inc.
- Date Received
- January 31, 1990
- Decision Date
- September 4, 1990
- Product Code
- HBN
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| HBN | Chair, Neurosurgical | FDA class 1 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HBN), ordered by most recent decision date.
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SURGI-QUIP MICROSCOPE STAND
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BINOCULAR OPERATING MICROSCOPES &
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| 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 |
| K900211 | SKYTRON UNIVERSE SERIES SURGICAL LIGHTS | Mar 19, 1990 | Substantially Equivalent |