510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K812104Substantially Equivalent

Siemens-Elema Psa 376

Siemens Corp., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K812104 is the FDA 510(k) clearance record for SIEMENS-ELEMA PSA 376, a class II device, cleared for Siemens Corp. on under FDA product code DTA (Tester, Pacemaker Electrode Function). FDA records list 82 510(k) clearances for Siemens Corp., from to . As of , FDA records show no recalls naming K812104.

Clearance record

Decision date
Received
(131 days to decision)
Product code
DTA Tester, Pacemaker Electrode Function
Regulation
21 CFR 870.3720
Device class
Class II
Review panel
Cardiovascular
Applicant
Siemens Corp. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code DTA

Trailing 12 months

FDA records hold no clearances under product code DTA in the trailing twelve months.

FDA records show no clearances under product code DTA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DTA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260