510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K822363Substantially Equivalent

Alta III ECG Recorder

Scole Engineering Co., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K822363 is the FDA 510(k) clearance record for ALTA III ECG RECORDER, a class II device, cleared for Scole Engineering Co. on under FDA product code DSH (Recorder, Magnetic Tape, Medical). FDA records list 4 510(k) clearances for Scole Engineering Co., from to . As of , FDA records show no recalls naming K822363.

Clearance record

Decision date
Received
(59 days to decision)
Product code
DSH Recorder, Magnetic Tape, Medical
Regulation
21 CFR 870.2800
Device class
Class II
Review panel
Cardiovascular
Applicant
Scole Engineering Co. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code DSH

Trailing 12 months
3 clearances under product code DSH in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DSH, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260