510(k) K840832

SERVOMED OXCARDIORE SPIROGRAPH 324/111 by Litton Medical Electronics — Product Code DRT

K840832 is an FDA 510(k) premarket notification submitted by Litton Medical Electronics for the device "SERVOMED OXCARDIORE SPIROGRAPH 324/111". The FDA issued a decision of Substantially Equivalent on September 20, 1984. The device falls under product code DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)), a Class II device regulated under 21 CFR 870.2300. Litton Medical Electronics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 1984
Date Received
February 24, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Device Class
Class II
Regulation Number
870.2300
Review Panel
CV
Submission Type