FLEX CONTROLLED PHOTOTHERAPY EQUIPMENT

Light, Ultraviolet, Dermatological

DAAVLIN DISTRIBUTING CO.

The following data is part of a premarket notification filed by Daavlin Distributing Co. with the FDA for Flex Controlled Phototherapy Equipment.

Pre-market Notification Details

Device IDK050695
510k NumberK050695
Device Name:FLEX CONTROLLED PHOTOTHERAPY EQUIPMENT
ClassificationLight, Ultraviolet, Dermatological
Applicant DAAVLIN DISTRIBUTING CO. 205 WEST BEMENT ST. Bryan,  OH  43506
ContactDavid W Swanson
CorrespondentDavid W Swanson
DAAVLIN DISTRIBUTING CO. 205 WEST BEMENT ST. Bryan,  OH  43506
Product CodeFTC  
CFR Regulation Number878.4630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-03-18
Decision Date2005-04-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B280803MI0604T60 K050695 000
B280811UV0024CX6E0 K050695 000
B280811UV0024CX5E0 K050695 000
B280811UV0016CX6E0 K050695 000
B280811UV0012CX6E0 K050695 000
B280810UV2400CX6E0 K050695 000
B280809HO1000CT605 K050695 000
B280809HO0010CX609 K050695 000
B280808HO0012CX509 K050695 000
B280808HO0012CT505 K050695 000
B280808HO0010CX608 K050695 000
B280808HO0010CX507 K050695 000
B280808HO0010CT604 K050695 000
B280808HO0008CX60 K050695 000
B280808HO0008CX50 K050695 000
B280808HO0008CT60 K050695 000
B280808HO0008CT50 K050695 000
B280808HO0006CT5ND01 K050695 000
B280811UV0028CX6E02 K050695 000
B280811UV1600CX6E0 K050695 000
B280800MI0010T60 K050695 000
B280803MI0010X60 K050695 000
B280803MI0010T60 K050695 000
B280802MI1000X60 K050695 000
B280802MI1000T60 K050695 000
B280802MI0604X60 K050695 000
B280802MI0604T60 K050695 000
B280802MI0406T60 K050695 000
B280802MI0010X60 K050695 000
B280802MI0010T60 K050695 000
B280801MI1000X60 K050695 000
B280801MI1000T60 K050695 000
B280801MI0604X60 K050695 000
B280801MI0604T60 K050695 000
B280801MI0406X60 K050695 000
B280801MI0010X60 K050695 000
B280801MI0010T60 K050695 000
B280800MI0010X60 K050695 000
B280808HO0004CX6ND04 K050695 000
B280808HO0004CX60 K050695 000
B280808HO0004CT6ND00 K050695 000
B280862NL0040MMCT3P0 K050695 000
B280862NL0040MMCT05 K050695 000
B280811UV2800CX6E02 K050695 000
B280811UV0028CX5E01 K050695 000
B280809HO1200CX50 K050695 000
B280809HO1200CT506 K050695 000
B280809HO1000CX609 K050695 000
B280809HO1000CX508 K050695 000
B280809HO1000CT504 K050695 000
B280808HO0010CT503 K050695 000
B280808HO0006CX5ND05 K050695 000
B280808HO0006CX50 K050695 000
B280808HO0006CT508 K050695 000
B280808HO0004CX5ND03 K050695 000
B280808HO0004CX5N03 K050695 000
B280808HO0004CX50 K050695 000
B280808HO0004CT5ND0 K050695 000
B280862NL0040PCCT0 K050695 000
B280862NL2020MMCT05 K050695 000
B280862NL2020MMCT3P0 K050695 000
B280808HO0004CT607 K050695 000
B280808HO0004CT506 K050695 000
B280801MI1000CX600 K050695 000
B280801MI1000CX50 K050695 000
B280801MI0604CX609 K050695 000
B280801MI0604CX508 K050695 000
B280801MI0010CX600 K050695 000
B280801MI0010CX50 K050695 000
B280864NL2020MMCT0 K050695 000
B280864NL4800PCCT08 K050695 000
B280864NL4800MMCT0 K050695 000
B280864NL4000PCCT00 K050695 000
B280864NL4000MMCT07 K050695 000
B280862NL4000PCCT3P0 K050695 000
B280862NL4000PCCT0 K050695 000
B280862NL4000MMCT3P0 K050695 000
B280862NL4000MMCT05 K050695 000
B2809801MI0010CX600 K050695 000
B280861PH4800X60 K050695 000
B280811UV0024T6E0 K050695 000
B280811UV0016X6I0 K050695 000
B280811UV0016X6E0 K050695 000
B280811UV0016T6I0 K050695 000
B280811UV0016T6E0 K050695 000
B280811UV0012X6I0 K050695 000
B280811UV0012T6I0 K050695 000
B280811UV0012T6E0 K050695 000
B280810UV2800X6I0 K050695 000
B280810UV2800T6I0 K050695 000
B280810UV2400X6I0 K050695 000
B280810UV2400T6I0 K050695 000
B280810UV1600T6I0 K050695 000
B280810UV1212T6I0 K050695 000
B280810UV1200X6I0 K050695 000
B280810UV1200T6I0 K050695 000
B280810UV0024T6I0 K050695 000
B280811UV0024T6I0 K050695 000
B280811UV0024X6E0 K050695 000
B280811UV0024X6I0 K050695 000
B280861PH3612X60 K050695 000
B280861PH2424X60 K050695 000
B280861PH1236X60 K050695 000
B280861PH0048X60 K050695 000
B280861PH0024X60 K050695 000
B280811UV2400X6E0 K050695 000
B280811UV1600X6I0 K050695 000
B280811UV1414X6E0 K050695 000
B280811UV1414T6E0 K050695 000
B280811UV1212X6I0 K050695 000
B280811UV1212X6E0 K050695 000
B280811UV1212T6I0 K050695 000
B280811UV1212T6E0 K050695 000
B280811UV0028X6I0 K050695 000
B280811UV0028X6E0 K050695 000
B280811UV0028T6I0 K050695 000
B280811UV0028T6E0 K050695 000
B280810UV0016X6I0 K050695 000
B280810UV0016T6I0 K050695 000
B280810UV0012X6I0 K050695 000
B280809HO0004T6ND0 K050695 000
B280809HO0004T60 K050695 000
B280808HO0012X60 K050695 000
B280808HO0012T60 K050695 000
B280808HO0010X60 K050695 000
B280808HO0010T60 K050695 000
B280808HO0008X60 K050695 000
B280808HO0008T60 K050695 000
B280808HO0006X6ND0 K050695 000
B280808HO0006X60 K050695 000
B280808HO0006T6ND0 K050695 000
B280808HO0006T60 K050695 000
B280808HO0004X6ND0 K050695 000
B280808HO0004X60 K050695 000
B280808HO0004T6ND220 K050695 000
B280808HO0004T6ND0 K050695 000
B280808HO0004T60 K050695 000
B280809HO0004X60 K050695 000
B280809HO0004X6ND0 K050695 000
B280809HO0006T60 K050695 000
B280810UV0012T6I0 K050695 000
B280809HO1200X60 K050695 000
B280809HO1200T60 K050695 000
B280809HO1000X60 K050695 000
B280809HO1000T60 K050695 000
B280809HO0800X60 K050695 000
B280809HO0800T60 K050695 000
B280809HO0600T6ND0 K050695 000
B280809HO0600T60 K050695 000
B280809HO0012X60 K050695 000
B280809HO0012T60 K050695 000
B280809HO0010X60 K050695 000
B280809HO0010T60 K050695 000
B280809HO0008X60 K050695 000
B280809HO0008T60 K050695 000
B280809HO0006X60 K050695 000
B280809HO0006T6ND0 K050695 000
B280803MI0604X60 K050695 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.