Quikpage Scanner

FDA 510(k) K822582 · Agilent Technologies

Substantially Equivalent

510(k) numberK822582

Submission

Device name
Quikpage Scanner
Applicant
Agilent Technologies
Walker, MI, US
Received
August 25, 1982
Decision date
September 21, 1982
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

510(k)DeviceApplicantDecision
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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K011824Agilent M2636B Telemon B Monitor (Telemon B)DSI · Special 07/02/2001SE
K010634Heartstream XL Defibibrillator/Monitor, Model M4735A, Heartstream XLT…MKJ · Traditional 06/11/2001SE
K011578M2376A Devicelink System, Model M2376AMWI · Special 06/08/2001SE
K003819Heartstream Attenuated Defibrillation Pads, Model M3870AMKJ · Traditional 05/02/2001SE
K011093Agilent Information Center Software for M3150,M3151,M3153 and M3154MHX · Special 05/01/2001SE
K010453M2376A Devicelink SystemMWI · Special 03/02/2001SE
K010342M2376A Devicelink System, Model M2376AMWI · Special 02/14/2001SE

Questions and answers

When was Quikpage Scanner cleared by the FDA?

Quikpage Scanner (K822582) received a 510(k) decision of Substantially Equivalent on September 21, 1982, 27 days after the submission was received.

What is the product code of K822582?

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