Cleared Special

AESPIRE 7900, AESPIRE VIEW

K122445 · Datex-Ohmeda · Anesthesiology
Oct 2012
Decision
63d
Days
Class 2
Risk

About This 510(k) Submission

K122445 is an FDA 510(k) clearance for the AESPIRE 7900, AESPIRE VIEW, a Gas-machine, Anesthesia (Class II — Special Controls, product code BSZ), submitted by Datex-Ohmeda (Madison, US). The FDA issued a Cleared decision on October 12, 2012, 63 days after receiving the submission on August 10, 2012. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5160.

Submission Details

510(k) Number K122445 FDA.gov
FDA Decision Cleared SESE
Date Received August 10, 2012
Decision Date October 12, 2012
Days to Decision 63 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BSZ — Gas-machine, Anesthesia
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5160

Similar Devices — BSZ Gas-machine, Anesthesia

All 186
Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and related 610i, 620i, 630i series enabled to retrofit RFID features); Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-1, SLS XXX, Multiple Models Pending Configuration)
K251352 · Codonics.Incorporated · Jul 2025
Atlan
K230931 · Dr?gerwerk AG & Co KGaA · Jul 2023
Carestation 750/750c
K213867 · Datex-Ohmeda, Inc. · Mar 2023
A8, A9 Anesthesia System
K201957 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Mar 2021
Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System
K191027 · Maquet Critical Care AB · Mar 2020
A7 Anesthesia System
K171292 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jan 2018