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K Number
K972379
Device Name
PRECISA N
Manufacturer
RUDOLF RIESTER GMBH & CO. KG
Date Cleared
1997-09-24

(90 days)

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

Precisa-N is a sphygmomanometer and is intended to measure the blood pressure (self-meaurement)

Device Description

Precisa-N is a sphygmomanometer

AI/ML Overview

I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a blood pressure cuff (Precisa-N). It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory information.

However, this document does not contain any information about:

  • Acceptance criteria or reported device performance in a table.
  • Details of a study (sample size, data provenance, number/qualifications of experts, adjudication method).
  • Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done.
  • Standalone performance (algorithm-only).
  • Type of ground truth used.
  • Training set size or how its ground truth was established.

Therefore, I cannot fulfill your request based on the provided text.

§ 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).