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Found 8 results
510(k) Data Aggregation
K Number
K102600Device Name
SIMPLYGO BREAST PUMP
Manufacturer
EVENFLO COMPANY, INC.
Date Cleared
2010-12-22
(103 days)
Product Code
HGX
Regulation Number
884.5160Why did this record match?
Applicant Name (Manufacturer) :
EVENFLO COMPANY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SimplyGo™ Breast Pump Kit is an electrically operated suction device used to express and collect milk from the breast(s) of lactating women.
Device Description
The SimplyGo™ Breast Pump Kit is an electrically operated suction device.
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K Number
K100435Device Name
AMEDA PLATINUM BREAST PUMP
Manufacturer
EVENFLO COMPANY, INC.
Date Cleared
2010-05-28
(101 days)
Product Code
HGX
Regulation Number
884.5160Why did this record match?
Applicant Name (Manufacturer) :
EVENFLO COMPANY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ameda Platinum Breast Pump is intended to express and collect milk from the mother's breast, to alleviate engorgement of the breast, maintain the ability of lactation, and provide mother's milk for future feedings when separation of mother and baby occurs.
Device Description
The Ameda Platinum electric breast pump is a simple and effective system for expressing milk from a mother's lactating breast(s). The Ameda Platinum Breast Pump is electric or battery operated. The Ameda Platinum Breast Pump utilizes the separately supplied predicate device. the Ameda HygieniKit.
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K Number
K092770Device Name
SIMPLYGO HANDS FREE BREAST PUMP
Manufacturer
EVENFLO COMPANY, INC.
Date Cleared
2009-10-09
(30 days)
Product Code
HGX
Regulation Number
884.5160Why did this record match?
Applicant Name (Manufacturer) :
EVENFLO COMPANY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Simply Go™ Breast Pump is an electrically operated suction device used to express and collect milk from the breast(s) of lactating woman.
Device Description
Not Found
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K Number
K082307Device Name
EVENFLO COMFORT SELECT PERFORMANCE BREAST PUMP KIT
Manufacturer
EVENFLO COMPANY, INC.
Date Cleared
2008-09-11
(29 days)
Product Code
HGX
Regulation Number
884.5160Why did this record match?
Applicant Name (Manufacturer) :
EVENFLO COMPANY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Evenflo Comfort Select Performance Breast Pump and Comfort Select Performance Dual Breast Pump are personal use battery/electric-powered suction devices used to express milk from the breast/s of lactating women.
Device Description
Not Found
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K Number
K053493Device Name
BERRY FRUITY TEETHER
Manufacturer
EVENFLO COMPANY, INC.
Date Cleared
2006-02-22
(69 days)
Product Code
KKO
Regulation Number
872.5550Why did this record match?
Applicant Name (Manufacturer) :
EVENFLO COMPANY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Evenflo Berry Fruity Teether is a personal use biting device used to cool and soothe the gums during the teething process.
Device Description
Not Found
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K Number
K052909Device Name
EVENFLO ELAN BREAST PUMP
Manufacturer
EVENFLO COMPANY, INC.
Date Cleared
2005-11-01
(15 days)
Product Code
HGX
Regulation Number
884.5160Why did this record match?
Applicant Name (Manufacturer) :
EVENFLO COMPANY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Evenflo Elan Breast Pump and the Evenflo Elan Dual Breast Pump are personal use battery and/or electric powered suction devices used to express milk from the breast (s) of lactating women.
Device Description
Not Found
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K Number
K022933Device Name
EVENFLO COMFORT SELECT AUTO-CYCLE BREAST PUMP KIT
Manufacturer
EVENFLO COMPANY, INC.
Date Cleared
2002-12-02
(89 days)
Product Code
HGX
Regulation Number
884.5160Why did this record match?
Applicant Name (Manufacturer) :
EVENFLO COMPANY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Evenflo Comfort Select Auto-cycle Breast Pump Kit is an electrically operated suction device used to express milk from the breast.
The Evenflo Comfort Select Breast Pump and Comfort Select Dual Breast Pump are battery/electric powered suction device used to express milk from the breast of lactating women.
Device Description
The Evenflo Comfort Select Auto-cycle Breast Pump is an electrically powered breast pump that uses the principle of negative suction to express milk from the breast. The Evenflo pump is sold in single and dual models. The dual model allows the user to pump one or both breasts at a time, and is designed with ergonomics in mind so as to be comfortable for the user. The single model applies the same ergonomics but is used to pump only one breast at a time.
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K Number
K013226Device Name
EVENFLO COMFORT EASE MANUAL BREAST PUMP KIT
Manufacturer
EVENFLO COMPANY, INC.
Date Cleared
2001-12-20
(84 days)
Product Code
HGY
Regulation Number
884.5150Why did this record match?
Applicant Name (Manufacturer) :
EVENFLO COMPANY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Like the predicate device, the proposed Eventlo Comfort East Pump . Like the predicate device to the latest of and one been a manage of any and is a non-powered, hand-operated (piston-type) suction device used to express milk from the breast of lactating women.
Device Description
non-powered, hand-operated (piston-type) suction device used to express milk from the breast of lactating women.
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