PRO-2000 LOW AIR LOSS THERAPY BED— 510(k) K926403

Name: FDA 510(k) clearance K926403
Creator: U.S. Food and Drug Administration
Published: 1993-07-30

Substantially Equivalent

Ch Administration, Inc.

FDA 510(k) clearance K926403 for PRO-2000 LOW AIR LOSS THERAPY BED, Substantially Equivalent on 1993-07-30. Applicant: Ch Administration, Inc.. Device class: 2.

Clearance details

Applicant: Ch Administration, Inc.
Product code: Code FNM
Device class: Class 2
Regulation: 21 CFR 880.5550
Advisory panel: General Hospital
Date received: 1992-12-21
Decision date: 1993-07-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dallas, TX, US

Download summary PDF View on FDA.gov ↗

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K974319 — MIGHTY AIR1998-01-22
K974070 — PHYSIO/10001998-01-06
K972549 — SIMPULSE1997-11-18

More clearances from Ch Administration, Inc.

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K953196 — CARDIO-SYSTEMS PRO-OP1995-11-08
K926402 — COMFORT CARE LOW AIR LOSS THERAPY BED1993-03-24

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.