510(k) K873672

MODEL 1010 PHYSIOLOGICAL SIGNAL TELEMETRY MONITOR by Novametrix Medical Systems, Inc. — Product Code DRG

K873672 is an FDA 510(k) premarket notification submitted by Novametrix Medical Systems, Inc. for the device "MODEL 1010 PHYSIOLOGICAL SIGNAL TELEMETRY MONITOR". The FDA issued a decision of Substantially Equivalent on December 3, 1987. The device falls under product code DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency), a Class II device regulated under 21 CFR 870.2910. Novametrix Medical Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 1987
Date Received
September 11, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transmitters And Receivers, Physiological Signal, Radiofrequency
Device Class
Class II
Regulation Number
870.2910
Review Panel
CV
Submission Type