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510(k) K812104

SIEMENS-ELEMA PSA 376 by Siemens Corp. — Product Code DTA

K812104 is an FDA 510(k) premarket notification submitted by Siemens Corp. for the device "SIEMENS-ELEMA PSA 376". The FDA issued a decision of Substantially Equivalent on December 2, 1981. The device falls under product code DTA (Tester, Pacemaker Electrode Function), a Class II device regulated under 21 CFR 870.3720. Siemens Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 2, 1981
Date Received
July 24, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tester, Pacemaker Electrode Function
Device Class
Class II
Regulation Number
870.3720
Review Panel
CV
Submission Type

Other clearances by Siemens Corp.

  • K150843 — syngo®.via (version VB10A) (April 24, 2015)
  • K123375 — SYNGO.VIA (November 20, 2012)
  • K110366 — SYNGO.CT CARDIAC FUNCTION (April 12, 2011)
  • K103360 — DIMENSION VISTA DIGITOXIN CALIBRATOR - DGTX CAL (December 17, 2010)
  • K081182 — MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL TEST - INDUCIBL (August 8, 2008)
  • K071310 — SYNGO CT ONCOLOGY SOFTWARE PACKAGE (June 8, 2007)
  • K063507 — SYNGO NEURO PBV CT (November 30, 2006)
  • K063373 — FLEX LOOP COIL SET 3T (November 17, 2006)
  • K053024 — SYNGO NEURO DSA CT (November 4, 2005)
  • K050867 — SYNGO BODY PERFUSION-CT (April 14, 2005)

Other clearances for product code DTA

  • K163008 — CareLink SmartSync Device Manager - Pacing System Analyzer (February 28, 2017)
  • K101982 — MERLIN PSA PATIENT CABLE EX 3150, CABLE ADAPTER EX3170, M ADAPTER EX3180 (December 21, 2010)
  • K073230 — MODELS ERA 300 AND 3105 PACING SYSTEM ANALYZERS (December 20, 2007)
  • K050884 — ADAPTER CABLE (May 19, 2005)
  • K033613 — MODIFICATION TO ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER (December 8, 2003)
  • K022360 — ERA 3000; PA-2 IS-1 ADAPTER; EK-4-N PACEMAKER TEST CABLE; ERA 3000 CHARGER; ERA (January 27, 2003)
  • K933069 — MODEL EP-2 CLINICAL STIMULATOR (October 21, 1993)
  • K791380 — VA 1000 (September 19, 1979)
  • K790503 — CARDIOTEST 2200 (May 17, 1979)

FDA data resources