510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K982228Substantially Equivalent

Fm Demodulator-4 Lead Model #8500-05 and Fm Demodulator-12 Lead Model # 8500-25

TZ Medical Inc., Lake Oswego OR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K982228 is the FDA 510(k) clearance record for FM DEMODULATOR-4 LEAD MODEL #8500-05 AND FM DEMODULATOR-12 LEAD MODEL # 8500-25, a class II device, cleared for Tz Medical, Inc. on under FDA product code DXH (Transmitters And Receivers, Electrocardiograph, Telephone). FDA records list 15 510(k) clearances for Tz Medical, Inc., from to . As of , FDA records show no recalls naming K982228.

Clearance record

Decision date
Received
(203 days to decision)
Product code
DXH Transmitters And Receivers, Electrocardiograph, Telephone
Regulation
21 CFR 870.2920
Device class
Class II
Review panel
Cardiovascular
Applicant
Tz Medical, Inc. 15858 SW Upper Boones Ferry Rd., Lake Oswego OR
510(k) summary
Statement
Third party review
No

Clearances, product code DXH

Trailing 12 months
4 clearances under product code DXH in the twelve months to October 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code DXH, trailing twelve months
MonthClearances
November 20251
December 20252
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260