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FDA 510(k)

EXTERNAL DEMAND PACEMAKER

K-Number: K923621 · 1993-05-19

ApplicantOscor Medical Corp.
Decision Date1993-05-19
Product CodeDTE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EXTERNAL DEMAND PACEMAKER 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 1993-05-19 under 510(k) number K923621. The device is classified under product code DTE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXTERNAL DEMAND PACEMAKER?

EXTERNAL DEMAND PACEMAKER is a medical device that received FDA 510(k) clearance on 1993-05-19. The listed applicant is Oscor Medical Corp.. The 510(k) number is K923621.

When did EXTERNAL DEMAND PACEMAKER receive FDA 510(k) clearance?

EXTERNAL DEMAND PACEMAKER received FDA 510(k) clearance on 1993-05-19, under 510(k) number K923621.

Who is the listed applicant for EXTERNAL DEMAND PACEMAKER?

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 EXTERNAL DEMAND PACEMAKER?

The FDA product code for EXTERNAL DEMAND PACEMAKER is DTE.

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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 LEADK912867OSCOR MEDICAL CORP PERMANENT PACING LEADK915008PERMANENT PACING PAD, MODIFICATIONK915007PERMANENT PACING LEADS, MODIFICATIONK913202IMPLANT PACING LEAD, TINED #3262, MODIFICATION

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Related Devices (Code: DTE)

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.

K241781Solo Pace ControlSolo Pace, Inc.K232721Lifetech Cardio Temporary PacemakerShenzhen Lifetech Cardio Medical Electronics Co., Ltd.K201011Medtronic Model 5392 External Pulse Generator (EPG)Medtronic, Inc.K190825Medtronic Model 5392 External Pulse Generator (EPG)Medtronic, Inc.K182839Lifetech Cardio Model 8301 Temporary PacemakerShenzhen Lifetech Cardio Medical Electronics Co., Ltd.K181973Medtronic Model 5392 External Pulse Generator (EPG)Medtronic, 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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