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FDA 510(k)

AP-CHECK

K-Number: K830877 · 1983-06-08

ApplicantGeneral Devices
Decision Date1983-06-08
Product CodeGYA
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

AP-CHECK is the device name listed in this FDA 510(k) record. The listed applicant is General Devices. It received FDA 510(k) clearance on 1983-06-08 under 510(k) number K830877. The device is classified under product code GYA. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AP-CHECK?

AP-CHECK is a medical device that received FDA 510(k) clearance on 1983-06-08. The listed applicant is General Devices. The 510(k) number is K830877.

When did AP-CHECK receive FDA 510(k) clearance?

AP-CHECK received FDA 510(k) clearance on 1983-06-08, under 510(k) number K830877.

Who is the listed applicant for AP-CHECK?

The FDA 510(k) record lists General Devices as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AP-CHECK?

The FDA product code for AP-CHECK is GYA.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing General Devices as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K013533EMS TELEMEDICINE OPTION (FOR GEMS SERIES 4000)K002089ROSETTA-LT/ROSETTA-RXK993202EIM-107 PREP-CHECKK940009GEMSCOM SERIES 6000, MODELS 6100, 6200 & 6300K935839GEMSCOM SERIES 5000,K921929GEMSCOM SERIES 300 12-LEAD ECG (12-LEAD OPTION)

View all 13 devices →

Related Devices (Code: GYA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K883869DERMTRODEWorld Precision Instruments, Inc.K854396RUB E-ZE-Z Instruments Co.K820040SC-IT IMPEDANCE TESTERCadwell Laboratories, Inc.K781475ELECTRODE IMPEDANCE TESTER-MODEL 500Life-Tech Instruments, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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