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FDA 510(k)

EXTERNAL PACEMAKER ANALYZER MODEL PMA-1

K-Number: K903966 · 1991-06-19

ApplicantBio-Tek Instruments, Inc.
Decision Date1991-06-19
Product CodeDTC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EXTERNAL PACEMAKER ANALYZER MODEL PMA-1 is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Tek Instruments, Inc.. It received FDA 510(k) clearance on 1991-06-19 under 510(k) number K903966. 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 EXTERNAL PACEMAKER ANALYZER MODEL PMA-1?

EXTERNAL PACEMAKER ANALYZER MODEL PMA-1 is a medical device that received FDA 510(k) clearance on 1991-06-19. The listed applicant is Bio-Tek Instruments, Inc.. The 510(k) number is K903966.

When did EXTERNAL PACEMAKER ANALYZER MODEL PMA-1 receive FDA 510(k) clearance?

EXTERNAL PACEMAKER ANALYZER MODEL PMA-1 received FDA 510(k) clearance on 1991-06-19, under 510(k) number K903966.

Who is the listed applicant for EXTERNAL PACEMAKER ANALYZER MODEL PMA-1?

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

What is the FDA product code for EXTERNAL PACEMAKER ANALYZER MODEL PMA-1?

The FDA product code for EXTERNAL PACEMAKER ANALYZER MODEL PMA-1 is DTC.

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Other records listing Bio-Tek Instruments, 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.

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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.K910595MODEL 5311B A-V PACING SYSTEM ANALYZERMedtronic Vascular

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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