PRESSUREGUARD IV— 510(k) K951112

Name: FDA 510(k) clearance K951112
Creator: U.S. Food and Drug Administration
Published: 1995-06-06

Substantially Equivalent

Span-America Medical Systems, Inc.

FDA 510(k) clearance K951112 for PRESSUREGUARD IV, Substantially Equivalent on 1995-06-06. Applicant: Span-America Medical Systems, Inc.. Device class: 2.

Clearance details

Applicant: Span-America Medical Systems, Inc.
Product code: Code FNM
Device class: Class 2
Regulation: 21 CFR 880.5550
Advisory panel: General Hospital
Date received: 1995-03-10
Decision date: 1995-06-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Greenville, SC, US

Download summary PDF View on FDA.gov ↗

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K972022 — ZAK-20001998-01-22
K974319 — MIGHTY AIR1998-01-22
K974070 — PHYSIO/10001998-01-06
K972549 — SIMPULSE1997-11-18

More clearances from Span-America Medical Systems, Inc.

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K972486 — PRESSUREGUARD IV1998-02-20
K960188 — PRESSUREGUARD: SELECTCARE1996-10-02
K961502 — LUBRICATING JELLY, LOW VISCOSITY1996-07-18
K961159 — POWERED LOW AIR LOSS MATTRESS SYSTEM1996-06-14
K960620 — PRESSUREGUARD: LOW AIR LOSS MATTRESS SYSTEM1996-04-25

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.