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FDA 510(k)

ESOPHAGEAL ECG PREAMPLIFIER & SIGNAL CON

K-Number: K802282 · 1980-10-10

ApplicantConsolidated Medical Equipment, Inc.
Decision Date1980-10-10
Product CodeDRR
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ESOPHAGEAL ECG PREAMPLIFIER & SIGNAL CON is the device name listed in this FDA 510(k) record. The listed applicant is Consolidated Medical Equipment, Inc.. It received FDA 510(k) clearance on 1980-10-10 under 510(k) number K802282. 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 ESOPHAGEAL ECG PREAMPLIFIER & SIGNAL CON?

ESOPHAGEAL ECG PREAMPLIFIER & SIGNAL CON is a medical device that received FDA 510(k) clearance on 1980-10-10. The listed applicant is Consolidated Medical Equipment, Inc.. The 510(k) number is K802282.

When did ESOPHAGEAL ECG PREAMPLIFIER & SIGNAL CON receive FDA 510(k) clearance?

ESOPHAGEAL ECG PREAMPLIFIER & SIGNAL CON received FDA 510(k) clearance on 1980-10-10, under 510(k) number K802282.

Who is the listed applicant for ESOPHAGEAL ECG PREAMPLIFIER & SIGNAL CON?

The FDA 510(k) record lists Consolidated Medical Equipment, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ESOPHAGEAL ECG PREAMPLIFIER & SIGNAL CON?

The FDA product code for ESOPHAGEAL ECG PREAMPLIFIER & SIGNAL CON is DRR.

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Other records listing Consolidated Medical Equipment, 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.

K854040I.V. DRESSINGK850130PRN ECG ELECTRODEK850132DISPOSABLE CONDUCTIVE ADHESIVE DIAGNOSTIC ECG ELECK850037CLOSED WOUND DRAINK844942PLURA-GARD CHEST DRAINAGE SYSTEMK850131CONDUCTIVE ADHESIVE POST-OP ELECTRODE-TENS

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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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