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K Number
K041689
Device Name
POLYURETHANE BLOOD PRESSURE CUFFS
Manufacturer
D. E. HOKANSON, INC.
Date Cleared
2004-08-06

(45 days)

Product Code
DXQ
Regulation Number
870.1120
Type
Special
Panel
CV
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Hokanson Digit and Penile cuffs are intended to measure blood pressure in small peripheral body parts. In general, the width of a blood pressure cuff should be approximately 40% of the diameter of the limb or digit being measured. The length of the cuff, in the case of these devices, is long enough to completely encircle the object being measured. The usage is the same as the predicate device which has been manufactured by our company since 1973.

Device Description

Hokanson Blood Pressure Digit and Penile cuffs

AI/ML Overview

I am sorry, but to answer your request with the specific details about acceptance criteria, device performance, and study information, I would need a clinical study report or a 510(k) summary that contains such data.

The provided document is an FDA 510(k) clearance letter for the "Hokanson Blood Pressure Digit and Penile Cuffs." This letter primarily:

  1. Confirms substantial equivalence: It states that the device is substantially equivalent to legally marketed predicate devices.
  2. Specifies the regulation number and class: It classifies the device as a Class II blood pressure cuff.
  3. Lists the indications for use: It states that the cuffs are intended to measure blood pressure in small peripheral body parts.

However, this document does not contain:

  • Acceptance criteria or reported device performance data.
  • Details about any specific study (sample size, data provenance, ground truth establishment, expert qualifications, adjudication method, MRMC studies, or standalone performance).
  • Information about the training set.

Typically, this kind of performance data and study design would be found in the 510(k) summary submitted by the manufacturer, which is often a separate document from the clearance letter itself.

Therefore, I cannot provide the requested table and detailed study information based solely on the text you provided.

§ 870.1120 Blood pressure cuff.

(a)
Identification. A blood pressure cuff is a device that has an inflatable bladder in an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The cuff is used in conjunction with another device to determine a subject's blood pressure.(b)
Classification. Class II (performance standards).