BED ROCKING DEVICE— 510(k) K801517

Name: FDA 510(k) clearance K801517
Creator: U.S. Food and Drug Administration
Published: 1980-10-10

Substantially Equivalent

Wesler

FDA 510(k) clearance K801517 for BED ROCKING DEVICE, Substantially Equivalent on 1980-10-10. Applicant: Wesler. Device class: 1.

Clearance details

Applicant: Wesler
Product code: Code FNJ
Device class: Class 1
Regulation: 21 CFR 880.5120
Advisory panel: General Hospital
Date received: 1980-07-01
Decision date: 1980-10-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, 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.