510(k) K831817

PATIENT MONITOR #RM-100 by Honeywell, Inc. — Product Code DRT

K831817 is an FDA 510(k) premarket notification submitted by Honeywell, Inc. for the device "PATIENT MONITOR #RM-100". The FDA issued a decision of Substantially Equivalent on October 31, 1983. The device falls under product code DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)), a Class II device regulated under 21 CFR 870.2300. Honeywell, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1983
Date Received
June 6, 1983
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