510(k) K882327

PACER SENSING ANALYZER (PSA 100) by Oscor Medical Corp. — Product Code DTC

K882327 is an FDA 510(k) premarket notification submitted by Oscor Medical Corp. for the device "PACER SENSING ANALYZER (PSA 100)". The FDA issued a decision of Substantially Equivalent on October 6, 1988. The device falls under product code DTC (Analyzer, Pacemaker Generator Function), a Class II device regulated under 21 CFR 870.3630. Oscor Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 6, 1988
Date Received
June 6, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Pacemaker Generator Function
Device Class
Class II
Regulation Number
870.3630
Review Panel
CV
Submission Type