PhySoftAMS®— 510(k) K232283

Substantially Equivalent

Physician Software Systems, LLC

FDA 510(k) clearance K232283 for PhySoftAMS®, Substantially Equivalent on 2023-12-14. Applicant: Physician Software Systems, LLC. Device class: 2.

Clearance details

Applicant: Physician Software Systems, LLC
Product code: Code MQS
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 2023-07-31
Decision date: 2023-12-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lisle, IL, US

Download summary PDF View on FDA.gov ↗

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K042566 — VASC-ALERT2004-11-08
K022963 — TRANSONIC SYRINGE WARMER, MODEL SYR-10002002-12-04
K021571 — TRANSONIC FLOW-QC SET MODEL ADT10102002-08-12

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