Search Results
Found 6 results
510(k) Data Aggregation
K Number
K080735Device Name
CRYOMINI
Manufacturer
ZIMMER ELEKTROMEDIZIN GMBH
Date Cleared
2008-04-04
(18 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
ZIMMER ELEKTROMEDIZIN GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CryoMini Cold Air Device is intended to minimize pain and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief for injections.
Device Description
The CryoMini consists of a refrigeration unit that creates cold air. The cold air is blown onto the skin using an air hose.
Ask a Question
K Number
K060395Device Name
CRYO, MODEL V6.0
Manufacturer
ZIMMER ELEKTROMEDIZIN GMBH
Date Cleared
2006-02-24
(9 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
ZIMMER ELEKTROMEDIZIN GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cryo V6.0 Cold Air Device is intended to minimize pain and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief for injections.
Device Description
The Cryo V6.0 consists of a refrigeration unit that creates cold air. The cold air is blown onto the skin using an air hose.
Ask a Question
K Number
K040727Device Name
CRYO 5
Manufacturer
ZIMMER ELEKTROMEDIZIN GMBH
Date Cleared
2004-04-23
(32 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
ZIMMER ELEKTROMEDIZIN GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cryo 5 Cold Air Device is intended, to minimize pain and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief for injections.
Device Description
The Cryo 5 consists of a refrigeration unit that creates cold air. The cold air is blown onto the skin using an air hose.
Ask a Question
K Number
K960969Device Name
GALVA 5-T
Manufacturer
ZIMMER ELEKTROMEDIZIN GMBH
Date Cleared
1996-05-15
(65 days)
Product Code
GZJ
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
ZIMMER ELEKTROMEDIZIN GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
K Number
K952536Device Name
SONO 5
Manufacturer
ZIMMER ELEKTROMEDIZIN GMBH
Date Cleared
1996-03-05
(278 days)
Product Code
IMI
Regulation Number
890.5300Why did this record match?
Applicant Name (Manufacturer) :
ZIMMER ELEKTROMEDIZIN GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
K Number
K954411Device Name
GALVA-5-M
Manufacturer
ZIMMER ELEKTROMEDIZIN GMBH
Date Cleared
1996-02-28
(160 days)
Product Code
IPF
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
ZIMMER ELEKTROMEDIZIN GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
Page 1 of 1