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FDA 510(k)

ELECTRODE/PACER SYSTEM ANALYZER PMA 400

K-Number: K810604 · 1981-04-14

ApplicantTelectronics, Inc.
Decision Date1981-04-14
Product CodeDTC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ELECTRODE/PACER SYSTEM ANALYZER PMA 400 is the device name listed in this FDA 510(k) record. The listed applicant is Telectronics, Inc.. It received FDA 510(k) clearance on 1981-04-14 under 510(k) number K810604. 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 ELECTRODE/PACER SYSTEM ANALYZER PMA 400?

ELECTRODE/PACER SYSTEM ANALYZER PMA 400 is a medical device that received FDA 510(k) clearance on 1981-04-14. The listed applicant is Telectronics, Inc.. The 510(k) number is K810604.

When did ELECTRODE/PACER SYSTEM ANALYZER PMA 400 receive FDA 510(k) clearance?

ELECTRODE/PACER SYSTEM ANALYZER PMA 400 received FDA 510(k) clearance on 1981-04-14, under 510(k) number K810604.

Who is the listed applicant for ELECTRODE/PACER SYSTEM ANALYZER PMA 400?

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

What is the FDA product code for ELECTRODE/PACER SYSTEM ANALYZER PMA 400?

The FDA product code for ELECTRODE/PACER SYSTEM ANALYZER PMA 400 is DTC.

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Other records listing Telectronics, Inc. as applicant

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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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