Hokanson

FDA UDI

Class II (US FDA UDI)

by D. E. Hokanson, Inc.

Identity

Trade Name: Hokanson FDA UDI
Generic Name: Limb plethysmograph FDA UDI
Device Name: PNEUMO PLETHYSMOGRAPH - An instrument which uses any size of blood pressure cuff as a sensing cuff to record volume changes in limbs and digits, sometimes called Volume Pulse Recording (VPR) or Pulse Volume Recording (PVR). The instrument plugs directly onto the a chart recorder for power, and to print volume waveforms. The instrument can be AC or DC coupled for different peripheral vascular diagnostic applications. FDA UDI
Model / Reference: MD6PN FDA UDI
Description: PNEUMO PLETHYSMOGRAPH - An instrument which uses any size of blood pressure cuff as a sensing cuff to record volume changes in limbs and digits, sometimes called Volume Pulse Recording (VPR) or Pulse Volume Recording (PVR). The instrument plugs directly onto the a chart recorder for power, and to print volume waveforms. The instrument can be AC or DC coupled for different peripheral vascular diagnostic applications. FDA UDI

Identifiers

Catalog Number: 00635 FDA UDI
Primary DI / UDI-DI: 00817065021358 FDA UDI
510(k) Number: K901592 FDA UDI
FDA Product Code: DXK FDA UDI
GMDN Term: Limb plethysmograph FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.2330 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Limb plethysmograph

Hokanson by D. E. Hokanson, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K901592 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: D. E. Hokanson, Inc.

Sources (1)

FDA UDI 1938d184-73a7-4118-91e7-2d4d4e34fedd 36 fields · synced Jun 8, 2026