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510(k) Data Aggregation
K Number
K001988Device Name
MODULAR
Manufacturer
HEYER AMERICA, INC.
Date Cleared
2001-02-05
(221 days)
Product Code
BSZ
Regulation Number
868.5160Why did this record match?
Applicant Name (Manufacturer) :
HEYER AMERICA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K000995Device Name
NARKOMAT, MODEL 2000
Manufacturer
HEYER AMERICA, INC.
Date Cleared
2000-10-11
(197 days)
Product Code
BSZ
Regulation Number
868.5160Why did this record match?
Applicant Name (Manufacturer) :
HEYER AMERICA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K963481Device Name
ANODYNE CC
Manufacturer
HEYER AMERICA, INC.
Date Cleared
1997-08-11
(342 days)
Product Code
BSZ
Regulation Number
868.5160Why did this record match?
Applicant Name (Manufacturer) :
HEYER AMERICA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Anodyne TM CC Anesthesia System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation.
Device Description
The HEYER America® Anodyne™ CC Anesthesia System is a standalone anesthesia device. The device is a reusable, non-sterile, life-supporting anesthesia machine for prescription use in hospitals, clinics and surgery centers. The device is software driven. Adequate software testing with respect to the new IEC 601-1-4 has been conducted on the device. The device is electrically operated.
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