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510(k) Data Aggregation
K Number
K973532Device Name
STEALTH, METERED DOSE INHALER (MDI) SPACER WITHOUT INTEGRAL ACTUATOR
Manufacturer
DHD DIEMOLDING HEALTHCARE DIV.
Date Cleared
1998-03-19
(182 days)
Product Code
CAF
Regulation Number
868.5630Why did this record match?
Applicant Name (Manufacturer) :
DHD DIEMOLDING HEALTHCARE DIV.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
1 - Purpose: The DHD Steath Metered Dose Intraler (MDI) Spacer (Without Integral Actuator) assists with the delivery of aerosolized medications when used in conjunction with commercially available Metered Dose Inhaler (MDI) canisters with then associated actuator elbows. In addition, for convenience, the MDI canister/elbow, may be stored inside of the Stealth when not in use (the spacer acts as the MDI canister/elbow holding chamber). 2 - Claims: 2.1 Use of the Stealth Spacer, without integral actuator, assists with the delivery of aerosolized medications from Metered Dose Inhaler (MDI) canisters. 2.2 Use of the Stealth Spacer reduces patient coordination and technique oriented problems associated with MDI drug delivery.
Device Description
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K Number
K970596Device Name
DHD EMERALD PRODUCT
Manufacturer
DHD DIEMOLDING HEALTHCARE DIV.
Date Cleared
1997-05-16
(87 days)
Product Code
BWF
Regulation Number
868.5690Why did this record match?
Applicant Name (Manufacturer) :
DHD DIEMOLDING HEALTHCARE DIV.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K961973Device Name
DHD ACE WITH MASK KIT
Manufacturer
DHD DIEMOLDING HEALTHCARE DIV.
Date Cleared
1996-08-15
(87 days)
Product Code
CAF
Regulation Number
868.5630Why did this record match?
Applicant Name (Manufacturer) :
DHD DIEMOLDING HEALTHCARE DIV.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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