Search Results
Found 3 results
510(k) Data Aggregation
K Number
K101538Device Name
HANDHELD MANUAL BREAST PUMP (AVENT MANUAL BREAST PUMP)
Manufacturer
PHILIPS ELECTRONICS UK LIMITED
Date Cleared
2010-11-05
(155 days)
Product Code
HGY, HGW
Regulation Number
884.5150Why did this record match?
Applicant Name (Manufacturer) :
PHILIPS ELECTRONICS UK LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Philips Avent Manual Breast Pump is intended to express and collect milk from the breasts of a lactating woman.
Device Description
The Philips Avent Manual Breast Pump expresses and collects milk from the breast of a lactating woman. The device is designed to be reusable by a single user. The pump diaphragm is activated by a manual pivoting handle. The duckbill valve closes to prevent backflow and seal the device under negative pressure as the handle is depressed. The valve then relaxes to allow milk flow into the bottle between pump actuations. Pumping can only be performed on one breast at a time. The vacuum level can be adjusted to comfort by varying the speed and travel of the manual handle. The device is comprised of the manual breast pump parts and feeding bottle. The Philips Avent Manual Breast Pump operates in one mode - manual. In the manual mode, the user controls the frequency and level of vacuum by varying the stroke/cycle of the control handle lever. All milk-contacting and human tissue-contacting components are manufactured from materials that meet the appropriate regulations regarding food contact and/or biocompatibility.
Ask a Question
K Number
K100495Device Name
PHILIPS AVENT DIGITAL THERMOMETER SET, MODEL SCH540
Manufacturer
PHILIPS ELECTRONICS UK LIMITED
Date Cleared
2010-06-22
(123 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
PHILIPS ELECTRONICS UK LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Philips AVENT Digital Thermometer Set is intended for determination of temperature. The set contains three items:
- A pacifier thermometer to detect baby's oral temperature.
- . An ordinary pacifier that can be used as a daily used regular pacifier.
- A digital flexible-tip thermometer that measures the oral, rectal, and axillary body temperature of humans.
Device Description
The Philips AVENT Digital Thermometer Set contains three items:
- A pacifier thermometer to detect baby's oral temperature.
- . An ordinary pacifier that can be used as a daily used regular pacifier.
- A digital flexible-tip thermometer that measures the oral, rectal, and axillary body temperature of humans.
Ask a Question
K Number
K090167Device Name
PHILIPS AVENT CLASSIC STAGE 2 AND 3 TEETHER, MODEL SCF882/01, SCF884/01, PHILIPS AVENT ANIMAL STAGE 2 AND 3 TEETHER,
Manufacturer
PHILIPS ELECTRONICS UK LIMITED
Date Cleared
2009-06-18
(147 days)
Product Code
KKO
Regulation Number
872.5550Why did this record match?
Applicant Name (Manufacturer) :
PHILIPS ELECTRONICS UK LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
Page 1 of 1