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510(k) Data Aggregation
K Number
K223835Device Name
MA-40, MA-112
Manufacturer
Medify Air LLC
Date Cleared
2023-09-18
(270 days)
Product Code
FRF
Regulation Number
880.5045Why did this record match?
Applicant Name (Manufacturer) :
Medify Air LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MA-40 and MA-112 are intended for use as room recirculating air cleaner. The systems are used for filtering out and inactivating airborne particles from the air for medical purposes.
The MA-40 has been demonstrated to reduce the following airborne microorganisms by >99.99% in a test chamber of 83ft3 (580 ft3)
BIOAEROSOL TYPE | SPECIES | DEVICE FAN SPEED | TOTAL TRIAL TIME (MINUTES)
-----------------|-----------------------------|------------------|-------------------------------
Virus | MS2 bacteriophage | Speed 3 | 30
| | Speed 2 | 45
| | Speed 1 | 90
Virus | Phi-X 174 bacteriophage | Speed 3 | 30
Bacterial | Staphylococcus Epidermidis | Speed 3 | 30
Bacterial | Escherichia coli | Speed 3 | 30
Bacterial | Bacillus Subtilis Endospore | Speed 3 | 30
| | Speed 2 | 45
| | Speed 1 | 120
Mold | Aspergillus Brasiliensis | Speed 3 | 30
The MA-112 has been demonstrated to reduce the following airborne microorganisms by >99.99% in a test chamber of 83ft3 (580 ft3)
BIOAEROSOL TYPE | SPECIES | DEVICE FAN SPEED | TOTAL TRIAL TIME (MINUTES)
-----------------|-----------------------------|------------------|-------------------------------
Virus | MS2 bacteriophage | Speed 4 | 20
| | Speed 3 |
| | Speed 2 |
| | Speed 1 |
Virus | Phi-X 174 bacteriophage | Speed 4 | 20
Bacterial | Staphylococcus Epidermidis | Speed 4 | 20
Bacterial | Escherichia coli | Speed 4 | 20
Bacterial | Bacillus Subtilis Endospore | Speed 4 | 20
| | Speed 3 |
| | Speed 2 |
| | Speed 1 |
Mold | Aspergillus Brasiliensis | Speed 4 | 20
Device Description
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