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510(k) Data Aggregation
K Number
K041952Device Name
ZIVF-AIRE
Manufacturer
Date Cleared
2005-09-08
(415 days)
Product Code
Regulation Number
884.6120Why did this record match?
Applicant Name (Manufacturer) :
ZANDER MEDICAL SUPPLIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The zIVF-AIRe Photo Catalytic Air Purification System models are designed to improve indoor air quality. The manufacturer's models QA-20, SP-20, and SP-20C for residential and general office use were re-engineered for use in IVF laboratories, in Reproductive, Endocrinology, and Andrology laboratories, as well as for general hospital use.
Device Description
zIVF-AIRe Photo-Catalytic Air Purification System
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K Number
K011327Device Name
DB1 EMBRYO FREEZE
Manufacturer
Date Cleared
2002-08-15
(471 days)
Product Code
Regulation Number
884.6120Why did this record match?
Applicant Name (Manufacturer) :
ZANDER MEDICAL SUPPLIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K002971Device Name
MTG - MINITUB HEATED STAGE SYSTEMS
Manufacturer
Date Cleared
2000-12-15
(84 days)
Product Code
Regulation Number
884.6120Why did this record match?
Applicant Name (Manufacturer) :
ZANDER MEDICAL SUPPLIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K002961Device Name
MINITUB MULTI-PURPOSE CASSETTES
Manufacturer
Date Cleared
2000-11-21
(60 days)
Product Code
Regulation Number
884.6120Why did this record match?
Applicant Name (Manufacturer) :
ZANDER MEDICAL SUPPLIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K003184Device Name
RS BIOTECH GALAXY 'R' CO2 INCUBATOR
Manufacturer
Date Cleared
2000-11-20
(40 days)
Product Code
Regulation Number
884.6120Why did this record match?
Applicant Name (Manufacturer) :
ZANDER MEDICAL SUPPLIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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