Cleared Traditional

HAEMONETICS CELL SAVER MINI SAVER AUTO. BLOOD SYS.

K872895 · Haemonetics Corp. · Anesthesiology
Jan 1988
Decision
172d
Days
Class 1
Risk

About This 510(k) Submission

K872895 is an FDA 510(k) clearance for the HAEMONETICS CELL SAVER MINI SAVER AUTO. BLOOD SYS., a Laryngoscope, Non-rigid (Class I — General Controls, product code CAL), submitted by Haemonetics Corp. (Braintree, US). The FDA issued a Cleared decision on January 11, 1988, 172 days after receiving the submission on July 23, 1987. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5530.

Submission Details

510(k) Number K872895 FDA.gov
FDA Decision Cleared SESE
Date Received July 23, 1987
Decision Date January 11, 1988
Days to Decision 172 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

Device Classification

Product Code CAL — Laryngoscope, Non-rigid
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.5530