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FDA 510(k)

TYPE 9210 S/ECG

K-Number: K903940 · 1991-12-04

ApplicantS & W Medico Teknik
Decision Date1991-12-04
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TYPE 9210 S/ECG is the device name listed in this FDA 510(k) record. The listed applicant is S & W Medico Teknik. It received FDA 510(k) clearance on 1991-12-04 under 510(k) number K903940. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TYPE 9210 S/ECG?

TYPE 9210 S/ECG is a medical device that received FDA 510(k) clearance on 1991-12-04. The listed applicant is S & W Medico Teknik. The 510(k) number is K903940.

When did TYPE 9210 S/ECG receive FDA 510(k) clearance?

TYPE 9210 S/ECG received FDA 510(k) clearance on 1991-12-04, under 510(k) number K903940.

Who is the listed applicant for TYPE 9210 S/ECG?

The FDA 510(k) record lists S & W Medico Teknik as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TYPE 9210 S/ECG?

The FDA product code for TYPE 9210 S/ECG is DSI.

Other records listing S & W Medico Teknik 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.

K9409339267 SPO2 ATHENA MODULEK913013TCPO2 9260 MODULE - SYSTEM ATHENAK915633MOD. TYPE 9230 TEMP 1 AND TEMP 2 SYSTEM ATHENAK9301349055 IRCA OPTION FOR SYSTEM ATHENA 9050 NTK9234189293/1 INTERFACE MODULEK911611SYSTEM ATHENA, MODIFICATION

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Related Devices (Code: DSI)

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.

K243349BodyGuardian Remote Monitoring System (BGRMS v3.0)Boston Scientific Cardiac Diagnostic Technologies, Inc.K250356MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)Infobionic, Inc.K240177Zio AT® device (A100A1001)iRhythm Technologies, Inc.K230265MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemInfobionic, Inc.K231276SmartCardia 7L PlatformSmartcardia SAK193104Unified Arrhythmia Diagnostic System PocketECG IVMedicalgorithmics S.A.

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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