BABYROCKER— 510(k) K881019

Substantially Equivalent

Cinventa AB

FDA 510(k) clearance K881019 for BABYROCKER, Substantially Equivalent on 1988-06-07. Applicant: Cinventa AB. Device class: 2.

Clearance details

Applicant: Cinventa AB
Product code: Code FMS
Device class: Class 2
Regulation: 21 CFR 880.5140
Advisory panel: General Hospital
Date received: 1988-03-10
Decision date: 1988-06-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sweden, SE

Download summary PDF View on FDA.gov ↗

Recent devices under product code FMS

K970334 — NATURE'S CRADLE1997-04-25
K963210 — VAIL 100 PEDIATRIC CRIB1996-11-13
K960747 — NATURE'S CRADLE MODEL C15001996-05-22
K960012 — STRYKER ADEL BASSINET1996-03-25
K951024 — NATURE'S CRADLE1995-06-05

Data sourced from openFDA. This site is unofficial and independent of the FDA.