510(k) K884897

FOUR-CHANNEL/EIGHT-CHANNEL THERMAL ARRAY RECORDER by Mennen Medical, Inc. — Product Code DSF

K884897 is an FDA 510(k) premarket notification submitted by Mennen Medical, Inc. for the device "FOUR-CHANNEL/EIGHT-CHANNEL THERMAL ARRAY RECORDER". The FDA issued a decision of Substantially Equivalent on March 9, 1989. The device falls under product code DSF (Recorder, Paper Chart), a Class I device regulated under 21 CFR 870.2810. Mennen Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 9, 1989
Date Received
November 23, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Recorder, Paper Chart
Device Class
Class I
Regulation Number
870.2810
Review Panel
CV
Submission Type