ACUCAIR CUSHION CONTINUOUS AIRFLOW SYSTEM— 510(k) K882161

Name: FDA 510(k) clearance K882161
Creator: U.S. Food and Drug Administration
Published: 1988-07-12

Substantially Equivalent

Ssi Medical Services, Inc.

FDA 510(k) clearance K882161 for ACUCAIR CUSHION CONTINUOUS AIRFLOW SYSTEM, Substantially Equivalent on 1988-07-12. Applicant: Ssi Medical Services, Inc.. Device class: 2.

Clearance details

Applicant: Ssi Medical Services, Inc.
Product code: Code FNM
Device class: Class 2
Regulation: 21 CFR 880.5550
Advisory panel: General Hospital
Date received: 1988-05-23
Decision date: 1988-07-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Ssi Medical Services, Inc.

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K943385 — CLINITRON ELEXIS1995-02-27
K942184 — CLINITRON AT HOME AIR FLUIDED THERAPY1995-02-07
K914351 — CLINITRON C-101992-02-14
K890523 — SUPERCAIR1989-02-10
K863047 — FLEXICAIR1986-09-05

Adverse events under product code FNM

product code FNM

Death: 22
Injury: 349
Other: 4
Total: 375

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.