510(k) K874442

DINAMAP VITAL SIGNS MONITOR/PULSE OXIMETER by Critikon Company, LLC — Product Code DQA

K874442 is an FDA 510(k) premarket notification submitted by Critikon Company, LLC for the device "DINAMAP VITAL SIGNS MONITOR/PULSE OXIMETER". The FDA issued a decision of Substantially Equivalent on February 18, 1988. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Critikon Company, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 18, 1988
Date Received
October 28, 1987
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