510(k) K850494

OHMEDA BIOX 3700 PULSE OXIMETER by Ohmeda Medical — Product Code DPZ

K850494 is an FDA 510(k) premarket notification submitted by Ohmeda Medical for the device "OHMEDA BIOX 3700 PULSE OXIMETER". The FDA issued a decision of Substantially Equivalent on March 28, 1985. The device falls under product code DPZ (Oximeter, Ear), a Class II device regulated under 21 CFR 870.2710. Ohmeda Medical has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 1985
Date Received
February 8, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oximeter, Ear
Device Class
Class II
Regulation Number
870.2710
Review Panel
AN
Submission Type