ABCO/GRANT ALTERNATING PRESSURE PAD & UT— 510(k) K800231

Name: FDA 510(k) clearance K800231
Creator: U.S. Food and Drug Administration
Published: 1980-02-26

Substantially Equivalent

Abco Dealers, Inc.

FDA 510(k) clearance K800231 for ABCO/GRANT ALTERNATING PRESSURE PAD & UT, Substantially Equivalent on 1980-02-26. Applicant: Abco Dealers, Inc.. Device class: 2.

Clearance details

Applicant: Abco Dealers, Inc.
Product code: Code FNM
Device class: Class 2
Regulation: 21 CFR 880.5550
Advisory panel: General Hospital
Date received: 1980-02-05
Decision date: 1980-02-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FNM

view all

K973169 — PRESSURE GUARD SITE SELECT (A)1998-02-20
K972022 — ZAK-20001998-01-22
K974319 — MIGHTY AIR1998-01-22
K974070 — PHYSIO/10001998-01-06
K972549 — SIMPULSE1997-11-18

More clearances from Abco Dealers, Inc.

view all

K905025 — DIGITAL THERMOMETER KITS1991-02-07
K882304 — DIGITAL THERMOMETER SHEATHS (ORAL AND RECTAL)1988-07-12
K880892 — BLOOD COLLECTING NEEDLE AND HOLDERS1988-04-21
K880894 — ALLERGIST SYRINGES1988-03-31
K872875 — STRETCH GAUZE BANDAGES1987-09-04

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.