Cleared Traditional

K972237 - HAND HELD MEDISPACER
(FDA 510(k) Clearance)

K972237 · Thayer Medical Corp. · Anesthesiology

Jul 1997

Decision

91d

Days

Class 2

Risk

K972237 is an FDA 510(k) clearance for the HAND HELD MEDISPACER, a Nebulizer (direct Patient Interface) (Class II — Special Controls, product code CAF), submitted by Thayer Medical Corp. (Tucson, US). The FDA issued a Cleared decision on July 31, 1997, 91 days after receiving the submission on May 1, 1997. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5630.

Submission Details

510(k) Number	K972237 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 01, 1997
Decision Date	July 31, 1997
Days to Decision	91 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Statement