INTELLISAVE AX700 ANESTHESIA SYSTEM— 510(k) K122063

Name: FDA 510(k) clearance K122063
Creator: U.S. Food and Drug Administration
Published: 2013-08-02

Substantially Equivalent

Philips Anesthesia Care

FDA 510(k) clearance K122063 for INTELLISAVE AX700 ANESTHESIA SYSTEM, Substantially Equivalent on 2013-08-02. Applicant: Philips Anesthesia Care. Device class: 2.

Clearance details

Applicant: Philips Anesthesia Care
Product code: Code BSZ
Device class: Class 2
Regulation: 21 CFR 868.5160
Advisory panel: Anesthesiology
Date received: 2012-07-13
Decision date: 2013-08-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rodovre, DK

Download summary PDF View on FDA.gov ↗

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K251352 — Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and related 610i, 620i, 630i series enabled to retrofit RFID features) +1 more2025-07-11
K230931 — Atlan2023-07-23
K213867 — Carestation 750/750c2023-03-28

Adverse events under product code BSZ

product code BSZ

Death: 23
Injury: 298
Malfunction: 32,987
Total: 33,308

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.