510(k) K924626

NOVAMETRIX MODEL 510 by Novametrix Medical Systems, Inc. — Product Code DQA

K924626 is an FDA 510(k) premarket notification submitted by Novametrix Medical Systems, Inc. for the device "NOVAMETRIX MODEL 510". The FDA issued a decision of Substantially Equivalent on December 3, 1993. 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
December 3, 1993
Date Received
September 14, 1992
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