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Anaesthesia Record Keeper

by Datex Division Instrumentarium Corp. 510(k)

Active United States

510(k) K923172

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK923172 Date9 Aug 1994ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
BSZ
Device Class
Class II
Regulation
21 CFR Part 868.5160
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Anaesthesia Record Keeper is a medical device designed to document and record essential anaesthesia-related parameters during surgical procedures. It falls under the category of anaesthesia monitoring equipment, ensuring accurate and comprehensive clinical data capture for patient safety and regulatory compliance. The device is intended to support anaesthesiologists in maintaining detailed records of vital signs, gas flows, and other critical metrics during anaesthesia administration.

This device is supplied as a reusable clinical tool, intended for use in operating rooms and anaesthesia care settings. It is classified under FDA product code BSZ and has received a 510(k) clearance, confirming its substantial equivalence to a predicate device. The device is not specified as sterile or MRI-safe, and no details regarding single-use or sterilisation methods are provided in the regulatory data. Storage and handling instructions are not included in the available specifications.

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