510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K894540Substantially Equivalent

Telemetry Receiver Accessory for the Cms 8000

Physio Control, Inc., Redmond WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K894540 is the FDA 510(k) clearance record for TELEMETRY RECEIVER ACCESSORY FOR THE CMS 8000, a class II device, cleared for Physio-Control Corp. on under FDA product code DXH (Transmitters And Receivers, Electrocardiograph, Telephone). FDA records list 108 510(k) clearances for Physio-Control Corp., from to . As of , FDA records show no recalls naming K894540.

Clearance record

Decision date
Received
(84 days to decision)
Product code
DXH Transmitters And Receivers, Electrocardiograph, Telephone
Regulation
21 CFR 870.2920
Device class
Class II
Review panel
Cardiovascular
Applicant
Physio-Control Corp. 11811 Willows Rd., NE, Redmond WA
Third party review
No

Clearances, product code DXH

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