Cleared Traditional

K870745 - STRYKER MODEL 977 BIRTHING BED (FDA 510(k) Clearance)

Feb 1987
Decision
2d
Days
Class 2
Risk

K870745 is an FDA 510(k) clearance for the STRYKER MODEL 977 BIRTHING BED. This device is classified as a Table, Obstetric (and Accessories) (Class II - Special Controls, product code KNC).

Submitted by Stryker Corp. (Kalamazoo, US). The FDA issued a Cleared decision on February 27, 1987, 2 days after receiving the submission on February 25, 1987.

This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4900.

Submission Details

510(k) Number K870745 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 1987
Decision Date February 27, 1987
Days to Decision 2 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary

Device Classification

Product Code KNC — Table, Obstetric (and Accessories)
Device Class Class II - Special Controls
CFR Regulation 21 CFR 884.4900