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Bt8m05s8axt

FDA UDI

Class II (US FDA UDI)

by Koven Technology, Inc.

Identity

Trade Name
BT8M05S8AXT FDA UDI
Generic Name
Noninvasive vascular ultrasound system probe FDA UDI
Device Name
8 MHz CW Doppler probe for the Smartdop XT. FDA UDI
Model / Reference
BT8M05S8AXT FDA UDI
Description
8 MHz CW Doppler probe for the Smartdop XT. FDA UDI

Identifiers

Catalog Number
BT8M05S8AXT FDA UDI
Primary DI / UDI-DI
00894912002937 FDA UDI
510(k) Number
K934638 FDA UDI
FDA Product Code
JOP FDA UDI
GMDN Term
Noninvasive vascular ultrasound system probe FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.2880 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Bt8m05s8axt by Koven Technology, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K934638 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Koven Technology, Inc.

Sources (1)

  • FDA UDI daa6bfde-adc1-426a-9479-69e39eb55938 36 fields · synced Jun 9, 2026