510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K854847Substantially Equivalent

Physio-Dyne Ecg/hr 3

Physio-Dyne Industrument Corp., Massapequa NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K854847 is the FDA 510(k) clearance record for PHYSIO-DYNE ECG/HR 3, a class II device, cleared for Physio-Dyne Industrument Corp. on under FDA product code DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)). FDA records list one 510(k) clearance for Physio-Dyne Industrument Corp. As of , FDA records show no recalls naming K854847.

Clearance record

Decision date
Received
(194 days to decision)
Product code
DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Regulation
21 CFR 870.2300
Device class
Class II
Review panel
Cardiovascular
Applicant
Physio-Dyne Industrument Corp. 35 Jeanette Dr., Massapequa NY
Third party review
No

Clearances, product code DRT

Trailing 12 months
4 clearances under product code DRT in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DRT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20261
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20261
October 20260