510(k) K771932

RECORDER, DINMAP, MODEL 950 by Applied Medical Research — Product Code DSH

K771932 is an FDA 510(k) premarket notification submitted by Applied Medical Research for the device "RECORDER, DINMAP, MODEL 950". The FDA issued a decision of Substantially Equivalent on November 7, 1977. The device falls under product code DSH (Recorder, Magnetic Tape, Medical), a Class II device regulated under 21 CFR 870.2800. Applied Medical Research has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 1977
Date Received
October 14, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Recorder, Magnetic Tape, Medical
Device Class
Class II
Regulation Number
870.2800
Review Panel
CV
Submission Type