510(k) K833973

MINOLTA SM-32 OXYGEN SATURATION MONIT by Marquest Medical Products, Inc. — Product Code DQA

K833973 is an FDA 510(k) premarket notification submitted by Marquest Medical Products, Inc. for the device "MINOLTA SM-32 OXYGEN SATURATION MONIT". The FDA issued a decision of Substantially Equivalent on May 9, 1984. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Marquest Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 1984
Date Received
November 16, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oximeter
Device Class
Class II
Regulation Number
870.2700
Review Panel
AN
Submission Type