ELECTROMED, INC.

Address:502 SIXTH AVE. N.W.,NEW PRAGUE,MN,56071,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Percussor, Powered-Electric (BYI) (10)

Premarket Exempt

Clear

SmartVest - B102090579S0100 Catalog Number : SQL-FILTER

Device Description : SQL® Replacement Filters - 2-Pack

Device Class : 2

Duns Number: 036514250

Premarket Exempt : No

Product Code : BYI

Prescription Use : Yes

Device Count : 1

SmartVest - B102090649S0100 Catalog Number : SQL-USA-I

Device Description : SQL-I Supplement Kit (USA)

Device Class : 2

Duns Number: 036514250

Premarket Exempt : No

Product Code : BYI

Prescription Use : Yes

Device Count : 1

SmartVest - B102090649S0200 Catalog Number : SQL-ESP-I

Device Description : SQL-I Supplement Kit (Spain)

Device Class : 2

Duns Number: 036514250

Premarket Exempt : No

Product Code : BYI

Prescription Use : Yes

Device Count : 1

SmartVest - B102090649S0300 Catalog Number : SQL-ITA-I

Device Description : SQL-I Supplement Kit (Italy)

Device Class : 2

Duns Number: 036514250

Premarket Exempt : No

Product Code : BYI

Prescription Use : Yes

Device Count : 1

SmartVest - B102090649S0400 Catalog Number : SQL-DEU-I

Device Description : SQL-I Supplement Kit (Germany)

Device Class : 2

Duns Number: 036514250

Premarket Exempt : No

Product Code : BYI

Prescription Use : Yes

Device Count : 1

SmartVest - B102090649S0500 Catalog Number : SQL-TWN-I

Device Description : SQL-I Supplement Kit (Taiwan)

Device Class : 2

Duns Number: 036514250

Premarket Exempt : No

Product Code : BYI

Prescription Use : Yes

Device Count : 1

SmartVest - B102090649S0600 Catalog Number : SQL-CAN-I

Device Description : SQL-I Supplement Kit (Canada)

Device Class : 2

Duns Number: 036514250

Premarket Exempt : No

Product Code : BYI

Prescription Use : Yes

Device Count : 1

SmartVest - B102090649S0700 Catalog Number : SQL-MEX-I

Device Description : SQL-I Supplement Kit (Mexico)

Device Class : 2

Duns Number: 036514250

Premarket Exempt : No

Product Code : BYI

Prescription Use : Yes

Device Count : 1

SmartVest - B102090649S0800 Catalog Number : SQL-HKG-I

Device Description : SQL-I Supplement Kit (Hong Kong)

Device Class : 2

Duns Number: 036514250

Premarket Exempt : No

Product Code : BYI

Prescription Use : Yes

Device Count : 1

SmartVest - B102090683S0100 Catalog Number : SQL-PEDESTAL

Device Description : Mobile Pedestal - SQL®

Device Class : 2

Duns Number: 036514250

Premarket Exempt : No

Product Code : BYI

Prescription Use : Yes

Device Count : 1

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