STRESS TABLE/ERGOMETER SYSTEM— 510(k) K792591

Clearance details

Applicant

Victoreen, Inc.

Product code

Code ISD

Device class

Class 2

Regulation

21 CFR 890.5360

Advisory panel

Physical Medicine

Date received

1979-12-17

Decision date

1980-01-04

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Walker, MI, US

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• K112121 — ERGOSELECT/GE2012-10-31
• K080545 — ACTITRAINER2008-07-24

• K982937 — MODEL 580-006 RADIATION THERAPY IONIZATION CHAMBER1998-11-19
• K974112 — VACUDAP, MODEL 2000, 20011998-01-29
• K973960 — MODEL 37-1851998-01-14
• K964952 — VERIDOSE V (FIVE), MODEL NUMBER 37-7051997-07-21
• K964785 — VERIDOSE DIODES1997-06-13

Other

2

Total

2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →