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FDA 510(k)

PACER SENSING ANALYZER (PSA 100)

K-Number: K882327 · 1988-10-06

ApplicantOscor Medical Corp.
Decision Date1988-10-06
Product CodeDTC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PACER SENSING ANALYZER (PSA 100) is the device name listed in this FDA 510(k) record. The listed applicant is Oscor Medical Corp.. It received FDA 510(k) clearance on 1988-10-06 under 510(k) number K882327. 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 PACER SENSING ANALYZER (PSA 100)?

PACER SENSING ANALYZER (PSA 100) is a medical device that received FDA 510(k) clearance on 1988-10-06. The listed applicant is Oscor Medical Corp.. The 510(k) number is K882327.

When did PACER SENSING ANALYZER (PSA 100) receive FDA 510(k) clearance?

PACER SENSING ANALYZER (PSA 100) received FDA 510(k) clearance on 1988-10-06, under 510(k) number K882327.

Who is the listed applicant for PACER SENSING ANALYZER (PSA 100)?

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

What is the FDA product code for PACER SENSING ANALYZER (PSA 100)?

The FDA product code for PACER SENSING ANALYZER (PSA 100) is DTC.

Related Clinical Trials

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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Other records listing Oscor Medical Corp. 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.

K964107OSCOR PERMANENT RETRACTABLE SCREW-IN PACING LEAD MODEL PRK925168MISCELLANEOUS PACING LEADK923621EXTERNAL DEMAND PACEMAKERK912867OSCOR MEDICAL CORP PERMANENT PACING LEADK915008PERMANENT PACING PAD, MODIFICATIONK915007PERMANENT PACING LEADS, MODIFICATION

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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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