Mini-Pecg

FDA 510(k) K832883 · Intersect Systems, Inc.

Substantially Equivalent

510(k) numberK832883

Submission

Device name
Mini-Pecg
Applicant
Intersect Systems, Inc.
Mchenry, IL, US
Received
August 26, 1983
Decision date
December 6, 1983
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
DPS – Electrocardiograph
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2340
Specialty
Cardiovascular

Other 510(k)s with product code DPS

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K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)DPS · Traditional Edan Instruments, Inc.07/02/2026SE
K251670MAC 7 Resting ECG Analysis SystemDPS · Traditional Ge Medical Systems Information Technologies, Inc.01/26/2026SE
K252361AccurECG Analysis System (v2.0)DPS · Traditional Accurkardia, Inc.12/22/2025SE
K252474Withings BeamO (SCT02)DPS · Traditional Withings11/10/2025SE
K250569Cardiologs Holter PlatformDPS · Traditional Philips France Commercial08/06/2025SE
K243252ZBPro DiagnosticDPS · Traditional Zbeats, Inc.07/10/2025SE
K243305Masimo W1DPS · Traditional Masimo Corporation04/03/2025SE
K241217CloudHRV™ System (100-01-001)DPS · Traditional Inmedix, Inc.01/16/2025SE
K241556Cardiac Workstation (5000); Cardiac Workstation (7000)DPS · Traditional Philips Medizin Systeme Böblingen GmbH12/17/2024SE
K240229Masimo W1DPS · Traditional Masimo Corporation08/08/2024SE

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K003892Total Bilirubin ReagentCIG · Traditional 02/20/2001SE
K983937Dual Vial Creatinine ReagentCGX · Traditional 01/06/1999SE
K974833Ck-Nac ReagentCGS · Traditional 02/13/1998SE
K941807Intersect Systems' Non-Mercuric Chloride ReagentCHG · Traditional 09/14/1994SE
K932888Intersect Systems Direct Amylase ReagentJFJ · Traditional 01/31/1994SE
K934039Intersect Systems HDL Cholesterol Reagent SetLBR · Traditional 11/16/1993SE
K932267Enzymatic CO2 Reagent, ModificationKHS · Traditional 09/24/1993SE

Questions and answers

When was Mini-Pecg cleared by the FDA?

Mini-Pecg (K832883) received a 510(k) decision of Substantially Equivalent on December 6, 1983, 102 days after the submission was received.

What is the product code of K832883?

The FDA product code is DPS – Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2340.