Search Results
Found 3 results
510(k) Data Aggregation
K Number
K140782Device Name
ULTRAMIST SYSTEM, ULTRAMIST GENERATOR, ULTRAMIST TREATMENT WAND, ULTRAMIST APPLICATOR
Manufacturer
CELLERATION, INC.
Date Cleared
2014-08-13
(135 days)
Product Code
NRB
Regulation Number
878.4410Why did this record match?
Applicant Name (Manufacturer) :
CELLERATION, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
MIST Systems produce a low energy ultrasound-generated mist used to promote wound healing through wound cleansing and maintenance debridement by the removal of fibrin, yellow slough, tissue exudates and bacteria.
Device Description
Not Found
Ask a Question
K Number
K122246Device Name
MIST 360 SINGLE USE APPLICATOR KIT, MIST 360 SINGLE USE APPLICATOR KIT, CASE OF 12
Manufacturer
CELLERATION, INC.
Date Cleared
2012-08-13
(17 days)
Product Code
NRB
Regulation Number
878.4410Why did this record match?
Applicant Name (Manufacturer) :
CELLERATION, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MIST Therapy System produces a low energy ultrasound generated mist used to promote wound healing through wound cleansing and maintenance debridement by the removal of yellow slough, fibrin, tissue exudates and bacteria.
Device Description
Not Found
Ask a Question
K Number
K050129Device Name
CELLERATION MIST THERAPY SYSTEM 5.1
Manufacturer
CELLERATION, INC.
Date Cleared
2005-05-17
(118 days)
Product Code
NRB
Regulation Number
878.4410Why did this record match?
Applicant Name (Manufacturer) :
CELLERATION, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MIST Therapy System produces a low energy ultrasound-generated mist used to promote wound healing through wound cleansing and maintenance debridement by the removal of yellow slough, fibrin, tissue exudates and bacteria.
Device Description
MIST Therapy System is a non-contact, low-energy ultrasound device, which utilizes continuous ultrasonic energy to atomize saline and deliver a continuous mist to the treatment site to promote wound healing.
Ask a Question
Page 1 of 1