510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K870545Substantially Equivalent

Andries Physical Assessment Computer

Andries Tek, Inc., Austin TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K870545 is the FDA 510(k) clearance record for ANDRIES PHYSICAL ASSESSMENT COMPUTER, a class I device, cleared for Andries Tek, Inc. on under FDA product code DQC (Phonocardiograph). FDA records list one 510(k) clearance for Andries Tek, Inc. As of , FDA records show no recalls naming K870545.

Clearance record

Decision date
Received
(185 days to decision)
Product code
DQC Phonocardiograph
Regulation
21 CFR 870.2390
Device class
Class I
Review panel
Cardiovascular
Applicant
Andries Tek, Inc. 8868 Research Blvd., Austin TX
Third party review
No

Clearances, product code DQC

Trailing 12 months

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

FDA records show no clearances under product code DQC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DQC, 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