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FDA 510(k)

OPUS PACEMAKERS (MODELS 4021, 4033, AND 4034)

K-Number: K952363 · 1995-08-15

ApplicantEla Medical, Inc.
Decision Date1995-08-15
Product CodeELA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OPUS PACEMAKERS (MODELS 4021, 4033, AND 4034) 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 1995-08-15 under 510(k) number K952363. The device is classified under product code ELA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPUS PACEMAKERS (MODELS 4021, 4033, AND 4034)?

OPUS PACEMAKERS (MODELS 4021, 4033, AND 4034) is a medical device that received FDA 510(k) clearance on 1995-08-15. The listed applicant is Ela Medical, Inc.. The 510(k) number is K952363.

When did OPUS PACEMAKERS (MODELS 4021, 4033, AND 4034) receive FDA 510(k) clearance?

OPUS PACEMAKERS (MODELS 4021, 4033, AND 4034) received FDA 510(k) clearance on 1995-08-15, under 510(k) number K952363.

Who is the listed applicant for OPUS PACEMAKERS (MODELS 4021, 4033, AND 4034)?

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 OPUS PACEMAKERS (MODELS 4021, 4033, AND 4034)?

The FDA product code for OPUS PACEMAKERS (MODELS 4021, 4033, AND 4034) is ELA.

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Other records listing Ela Medical, 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.

K042002SYNESCOPE, EASYSCOPE, SYNECOM, HOLTERREADERK032466SPIDERVIEWK002817SYNETECK993448STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADSK000029STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADSK990727SYNEFLASH & SYNEVIEW

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Related Devices (Code: ELA)

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.

K854168TRAVENOL DISPOSABLE DENTAL SCALERS/CURETTESTravenol Laboratories, S.A.K823326DENTAL INSTRUMENTS - CUTTING INSTRUMENTMiltex, Inc.K801974ANALYTIC TECH. METAL POINT HEATER #3001Analytic Technology

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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