Cleared Traditional

K852994 - REICHERT FLEXIBLE LARYNGOSCOPE, MODEL LS-11 (FDA 510(k) Clearance)

K852994 · Reichert-Jung, Inc. · Anesthesiology device

Jul 1985

Decision

14d

Days

Class 1

Risk

K852994 is an FDA 510(k) clearance for the REICHERT FLEXIBLE LARYNGOSCOPE, MODEL LS-11. This device is classified as a Laryngoscope, Non-rigid (Class I - General Controls, product code CAL).

Submitted by Reichert-Jung, Inc. (Southbridge, US). The FDA issued a Cleared decision on July 29, 1985, 14 days after receiving the submission on July 15, 1985.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5530.

Submission Details

510(k) Number	K852994 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 15, 1985
Decision Date	July 29, 1985
Days to Decision	14 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	—