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510(k) Data Aggregation
K Number
K094003Device Name
REVIVATOR
Manufacturer
Date Cleared
2010-09-17
(263 days)
Product Code
Regulation Number
868.5915Why did this record match?
Applicant Name (Manufacturer) :
HERSILL, S.L.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Revivator resuscitator is intended for pulmonary resuscitation.
The adult resuscitator is for people with a body weight of more than 30 kg (66 lbs)
The child resuscitator is for children with a body weight between 7 and 30 kg (15-66 lbs)
The infant resuscitator is for infants with a body weight up to 7 kg (15 lbs)
Device Description
A resuscitator is a device using positive pressure to inflate the lungs of an unconscious person who is not breathing, in order to keep him oxygenated and alive. The manual resuscitators basically consist of a mask and a large hand-squeezed plastic bulb using ambient air, or supplemental oxygen. The air and oxygen flows into the resuscitator bag. And compressing the bag, the patient is ventilated. In order not to apply a high pressure to the patient's airways, the resuscitators include a pressure-limiting valve.
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K Number
K093241Device Name
V7 PORTABLE SUCTION UNITS
Manufacturer
Date Cleared
2010-04-27
(194 days)
Product Code
Regulation Number
878.4780Why did this record match?
Applicant Name (Manufacturer) :
HERSILL, S.L.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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