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FDA 510(k)

PACING SYSTEM ANALYZER PSA SCE-22

K-Number: K791975 · 1980-01-31

ApplicantEla Medical, Inc.
Decision Date1980-01-31
Product CodeDTC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PACING SYSTEM ANALYZER PSA SCE-22 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 1980-01-31 under 510(k) number K791975. The device is classified under product code DTC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PACING SYSTEM ANALYZER PSA SCE-22?

PACING SYSTEM ANALYZER PSA SCE-22 is a medical device that received FDA 510(k) clearance on 1980-01-31. The listed applicant is Ela Medical, Inc.. The 510(k) number is K791975.

When did PACING SYSTEM ANALYZER PSA SCE-22 receive FDA 510(k) clearance?

PACING SYSTEM ANALYZER PSA SCE-22 received FDA 510(k) clearance on 1980-01-31, under 510(k) number K791975.

Who is the listed applicant for PACING SYSTEM ANALYZER PSA SCE-22?

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 PACING SYSTEM ANALYZER PSA SCE-22?

The FDA product code for PACING SYSTEM ANALYZER PSA SCE-22 is DTC.

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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: DTC)

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.

K170815PSA CableBoston Scientific CorporationK083674PK-141 PATIENT CABLEBiotronik, Inc.K011729SIGMA PACE EXTERNAL PACEMAKER ANALYZER MODEL #1000Dni Nevada, Inc.K002497MODEL 4810 ANALYZER OUTPUT ADAPTERPace MedicalK961582EXTERNAL PACEMAKER ANALYZER, MODEL PMT 100North American Technical Services Corp.K903966EXTERNAL PACEMAKER ANALYZER MODEL PMA-1Bio-Tek Instruments, 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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