510(k) K851277

MICROSPIRO-SDS by Medical Equipment Designs, Inc. — Product Code BZG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 1985
Date Received
April 1, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spirometer, Diagnostic
Device Class
Class II
Regulation Number
868.1840
Review Panel
AN
Submission Type