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K Number
K012444
Device Name
ABN ANEROID SPHYGMOMANOMETER
Manufacturer
PT. SUGIH INSTRUMENDO ABADI
Date Cleared
2001-08-16

(15 days)

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

An Aneroid Sphygmomanometer is a non-invasive medical device intended to measure blood pressure by means of a manually inflatable cuff and a manometer analog gauge. These devices will be used by physicians, nurses, paramedics and retail consumers.

Device Description

An Aneroid Sphygmomanometer is a non-invasive medical device intended to measure blood pressure by means of a manually inflatable cuff and a manometer analog gauge.

AI/ML Overview

The provided text is a 510(k) Pre-Market Notification from the FDA concerning an ABN Aneroid Sphygmomanometer. This document is a regulatory approval for the device based on its substantial equivalence to a legally marketed predicate device.

It does NOT contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The document primarily states:

  • The device's trade name: ABN Aneroid Sphygmomanometer
  • Its regulation number: 21 CFR 870.1120
  • Its regulatory class: Class II (two)
  • Its product code: 78 DXQ
  • The date of receipt and approval.
  • The FDA's determination of substantial equivalence to a predicate device.
  • Indications for Use: "An Aneroid Sphygmomanometer is a non-invasive medical device intended to measure the blood pressure of a patient by means of a manually inflatable cuff and a manometer analog gauge. These devices will be used by physicians, nurses, paramedics and retail consumers."

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving device performance because it is not present in the provided text. This type of information would typically be found in a separate study report or a detailed technical submission, not in this specific FDA approval letter.

§ 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).