510(k) K010451

NOVAMETRIX MARQUETTE COMPATIBLE SENSORS by Novametrix Medical Systems, Inc. — Product Code DQA

K010451 is an FDA 510(k) premarket notification submitted by Novametrix Medical Systems, Inc. for the device "NOVAMETRIX MARQUETTE COMPATIBLE SENSORS". The FDA issued a decision of Substantially Equivalent on April 25, 2001. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Novametrix Medical Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 25, 2001
Date Received
February 15, 2001
Clearance Type
Abbreviated
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