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FDA 510(k)

ASC-950 ECG AMPLIFIER

K-Number: K894161 · 1989-08-03

ApplicantAstro-Med, Inc.
Decision Date1989-08-03
Product CodeDRR
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ASC-950 ECG AMPLIFIER is the device name listed in this FDA 510(k) record. The listed applicant is Astro-Med, Inc.. It received FDA 510(k) clearance on 1989-08-03 under 510(k) number K894161. The device is classified under product code DRR. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASC-950 ECG AMPLIFIER?

ASC-950 ECG AMPLIFIER is a medical device that received FDA 510(k) clearance on 1989-08-03. The listed applicant is Astro-Med, Inc.. The 510(k) number is K894161.

When did ASC-950 ECG AMPLIFIER receive FDA 510(k) clearance?

ASC-950 ECG AMPLIFIER received FDA 510(k) clearance on 1989-08-03, under 510(k) number K894161.

Who is the listed applicant for ASC-950 ECG AMPLIFIER?

The FDA 510(k) record lists Astro-Med, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ASC-950 ECG AMPLIFIER?

The FDA product code for ASC-950 ECG AMPLIFIER is DRR.

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Other records listing Astro-Med, Inc. 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.

K081551TWIN NEUROTRAC-IIIK050425AURA-PSGK033978ADAMK970951GRASS BRAINWAVE SOFTWAREK963669GRASS MODEL 15 NEURODATA AMPLIFIER SYSTEMK934644K3 SYSTEM

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Related Devices (Code: DRR)

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.

K022660BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117Biocheck, Inc.K971570EPXPRESS SYSTEM (TIMBERWOLF REVISION) /000391Quinton Electrophysiology Corp.K925346EP AMP, MODEL #901Quinton Electrophysiology Corp.K914381HORIZON 9000/HIS OPTION AMPLIFIERMennen Medical, Inc.K911935CARDIAC ELECTROPHYSICAL LEAD SELECTOR, MODIFIEDGould, Inc.K910307CARDIOLAB AMPLIFIER MODULE (CAM)Prucka Engineering, 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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