Cleared Traditional

ROCKET INTRAUTERINE DEPTH SOUND

K884684 · A & A Medical, Inc. · Obstetrics & Gynecology
Dec 1988
Decision
42d
Days
Class 1
Risk

About This 510(k) Submission

K884684 is an FDA 510(k) clearance for the ROCKET INTRAUTERINE DEPTH SOUND, a Sound, Uterine (Class I — General Controls, product code HHM), submitted by A & A Medical, Inc. (Branford, US). The FDA issued a Cleared decision on December 20, 1988, 42 days after receiving the submission on November 8, 1988. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.

Submission Details

510(k) Number K884684 FDA.gov
FDA Decision Cleared SESE
Date Received November 08, 1988
Decision Date December 20, 1988
Days to Decision 42 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary —

Device Classification

Product Code HHM — Sound, Uterine
Device Class Class I — General Controls
CFR Regulation 21 CFR 884.4530