COT, FOLDING HOSPITAL ALUMINUM - MANUAL BED— 510(k) K861678

Name: FDA 510(k) clearance K861678
Creator: U.S. Food and Drug Administration
Published: 1986-05-08

Substantially Equivalent

Sierra Corp.

FDA 510(k) clearance K861678 for COT, FOLDING HOSPITAL ALUMINUM - MANUAL BED, Substantially Equivalent on 1986-05-08. Applicant: Sierra Corp.. Device class: 1.

Clearance details

Applicant: Sierra Corp.
Product code: Code FNJ
Device class: Class 1
Regulation: 21 CFR 880.5120
Advisory panel: General Hospital
Date received: 1986-05-01
Decision date: 1986-05-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Smith, AR, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FNJ

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K934298 — KING KRIB1994-01-26
K892877 — CRADLE, HOSPITAL BED CLOTHING1989-06-15
K885241 — BED, ADJUSTABLE, HOSPITAL, FOLDING, FIELD, W/O MAT1989-02-24
K884542 — SIC 3999 FOLDING ADJUSTABLE HOSPITAL BED1988-11-21
K881725 — ENVIROTENT (BED)1988-11-08

Adverse events under product code FNJ

product code FNJ

Death: 6
Total: 6

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.