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Found 4 results
510(k) Data Aggregation
K Number
K001742Device Name
RESUSCI INFLATE-A-SHIELD CPR BARRIER
Manufacturer
LAERDAL MEDICAL CORP.
Date Cleared
2000-10-06
(120 days)
Product Code
CBP
Regulation Number
868.5870Why did this record match?
Applicant Name (Manufacturer) :
LAERDAL MEDICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K962361Device Name
TRACHLIGHT STYLET AND TRACHEAL LIGHTWAND
Manufacturer
LAERDAL MEDICAL CORP.
Date Cleared
1996-09-05
(78 days)
Product Code
BSR
Regulation Number
868.5790Why did this record match?
Applicant Name (Manufacturer) :
LAERDAL MEDICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K954771Device Name
TRACHLIGHT STYLET & TRACHEAL LIGHTWAND (ORIGINAL APPLICATION NAME: STYLETT & TRACHEAL LIGHTWAND)
Manufacturer
LAERDAL MEDICAL CORP.
Date Cleared
1996-05-09
(205 days)
Product Code
BSR
Regulation Number
868.5790Why did this record match?
Applicant Name (Manufacturer) :
LAERDAL MEDICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Trachlight is designed to facilitate the placement of endotracheal tubes of various sizes and lengths for both orotracheal and nasotracheal intubations.
Device Description
The Trachlight includes a wand with an incandescent light bulb at its tip that is placed inside the endotracheal tube prior to intubation, with the light bulb positioned at the end of the endotracheal tube. Light from the light bulb helps provide a guide for the clinician during the intubation process, and light emanating from the light bulb can be seen through the patient's tissue when the end of the endotracheal tube is properly positioned in the patient's trachea. The Trachlight consists of a reusable handle that contains the batteries and electronic circuits to apply power to the light bulb; a sterile, flexible wand that contains the light bulb at the tip; and a stylet that slides into the wand and acts as a stiffening member when needed.
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K Number
K954609Device Name
HEARTSTART 911
Manufacturer
LAERDAL MEDICAL CORP.
Date Cleared
1996-01-04
(92 days)
Product Code
MKJ
Regulation Number
870.5310Why did this record match?
Applicant Name (Manufacturer) :
LAERDAL MEDICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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