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Found 5 results
510(k) Data Aggregation
K Number
K101537Device Name
AIM 200, MAJOR SURGICAL LIGHT
Manufacturer
BURTON MEDICAL PRODUCTS CORP.
Date Cleared
2010-09-30
(119 days)
Product Code
FSY
Regulation Number
878.4580Why did this record match?
Applicant Name (Manufacturer) :
BURTON MEDICAL PRODUCTS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AIM 200® OR Major Surgical Light is designed to provide the required illumination for surgeries, procedures, and examinations of patients. The AIM 2000 OR Major Surgical Light is to be used with various mounting configurations in operating rooms, examination rooms, emergency rooms and all other health care facilities where the need for additional illumination exists.
Device Description
The new AIM 200® OR is intended to be used in Acute care arena in operating theaters, emergency rooms, trauma centers, and endo-suites as well as in ASC's for endo-suites, plastic surgery, ophthalmology and orthopedic procedures. It is available in floor, wall, single ceiling and double ceiling models. The new AIM 200® OR combines the smart and versatile styling of the existing AIM 50® and AIM 100® with the increased luminance of a Major OR product. The AIM 200® OR uses proven AIM 100® optical modules at increased powers to yield illuminance of 90,000 Lux at 1 meter while meeting the D50/D10 light distribution ratio required by the IEC 60601-2-41 standard for Major Surgical Lighting.
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K Number
K042395Device Name
OUTPATIENT III MINOR SURGERY LIGHT
Manufacturer
BURTON MEDICAL PRODUCTS CORP.
Date Cleared
2004-12-01
(90 days)
Product Code
FSY
Regulation Number
878.4580Why did this record match?
Applicant Name (Manufacturer) :
BURTON MEDICAL PRODUCTS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Outpatient® III Minor Surgery Light is designed to provide the required illumination for examinations of patients. The Outpatient® III light is to be used with various mounting configurations in operating rooms, examination rooms, and other health care facilities where the need for additional illumination exists.
Device Description
Not Found
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K Number
K000639Device Name
VISIONARY 2000
Manufacturer
BURTON MEDICAL PRODUCTS CORP.
Date Cleared
2000-05-25
(90 days)
Product Code
FSY
Regulation Number
878.4580Why did this record match?
Applicant Name (Manufacturer) :
BURTON MEDICAL PRODUCTS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K963682Device Name
GENIE' SINGLE CEILING AND DOUBLE CEILING
Manufacturer
BURTON MEDICAL PRODUCTS CORP.
Date Cleared
1996-11-13
(71 days)
Product Code
FSY
Regulation Number
878.4580Why did this record match?
Applicant Name (Manufacturer) :
BURTON MEDICAL PRODUCTS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K961843Device Name
GENIE
Manufacturer
BURTON MEDICAL PRODUCTS CORP.
Date Cleared
1996-08-22
(101 days)
Product Code
FSY
Regulation Number
878.4580Why did this record match?
Applicant Name (Manufacturer) :
BURTON MEDICAL PRODUCTS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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