Cleared Traditional

K901763 - NATURE'S CRADLE(TM) (FDA 510(k) Clearance)

Mar 1991
Decision
338d
Days
Class 2
Risk

K901763 is an FDA 510(k) clearance for the NATURE'S CRADLE(TM). This device is classified as a Bed, Pediatric Open Hospital (Class II - Special Controls, product code FMS).

Submitted by Infant Advantage, Inc. (Milpitas, US). The FDA issued a Cleared decision on March 22, 1991, 338 days after receiving the submission on April 18, 1990.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5140.

Submission Details

510(k) Number K901763 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 1990
Decision Date March 22, 1991
Days to Decision 338 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary

Device Classification

Product Code FMS — Bed, Pediatric Open Hospital
Device Class Class II - Special Controls
CFR Regulation 21 CFR 880.5140