FDA 510(k)

ELA MEDICAL CARDIAC PACEMAKERS MULTIL 2 #1251&2251

K-Number: K853017 · 1985-07-25

Decision Date1985-07-25

Product CodeDXY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

ELA MEDICAL CARDIAC PACEMAKERS MULTIL 2 #1251&2251 is the device name listed in this FDA 510(k) record. The listed applicant is Ela Medical, Inc.. It received FDA 510(k) clearance on 1985-07-25 under 510(k) number K853017. The device is classified under product code DXY. It was reviewed by the CV advisory panel. Product code DXY falls under the category of Clinical Chemistry, which covers reagents and instruments for chemical analysis of clinical samples. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELA MEDICAL CARDIAC PACEMAKERS MULTIL 2 #1251&2251?

ELA MEDICAL CARDIAC PACEMAKERS MULTIL 2 #1251&2251 is a medical device that received FDA 510(k) clearance on 1985-07-25. The listed applicant is Ela Medical, Inc.. The 510(k) number is K853017.

When did ELA MEDICAL CARDIAC PACEMAKERS MULTIL 2 #1251&2251 receive FDA 510(k) clearance?

ELA MEDICAL CARDIAC PACEMAKERS MULTIL 2 #1251&2251 received FDA 510(k) clearance on 1985-07-25, under 510(k) number K853017.

Who is the listed applicant for ELA MEDICAL CARDIAC PACEMAKERS MULTIL 2 #1251&2251?

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

What is the FDA product code for ELA MEDICAL CARDIAC PACEMAKERS MULTIL 2 #1251&2251?

The FDA product code for ELA MEDICAL CARDIAC PACEMAKERS MULTIL 2 #1251&2251 is DXY. This falls under the Clinical Chemistry category.

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Other records listing Ela Medical, Inc. as applicant

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Related Devices (Code: DXY)

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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.