510(k) K933278

INTERMEDICS TRIANGLE CHEST PROBE MODEL 526-04 by Intermedics, Inc. — Product Code KRG

K933278 is an FDA 510(k) premarket notification submitted by Intermedics, Inc. for the device "INTERMEDICS TRIANGLE CHEST PROBE MODEL 526-04". The FDA issued a decision of Substantially Equivalent on March 15, 1995. The device falls under product code KRG (Programmer, Pacemaker), a Class III device regulated under 21 CFR 870.3700. Intermedics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 1995
Date Received
June 29, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Programmer, Pacemaker
Device Class
Class III
Regulation Number
870.3700
Review Panel
CV
Submission Type