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FDA 510(k)

EXTERNAL PULSE GENERATOR FOR TEMP. STIM

K-Number: K831768 · 1983-12-16

ApplicantOscor, Inc.
Decision Date1983-12-16
Product CodeDTE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EXTERNAL PULSE GENERATOR FOR TEMP. STIM is the device name listed in this FDA 510(k) record. The listed applicant is Oscor, Inc.. It received FDA 510(k) clearance on 1983-12-16 under 510(k) number K831768. 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 PULSE GENERATOR FOR TEMP. STIM?

EXTERNAL PULSE GENERATOR FOR TEMP. STIM is a medical device that received FDA 510(k) clearance on 1983-12-16. The listed applicant is Oscor, Inc.. The 510(k) number is K831768.

When did EXTERNAL PULSE GENERATOR FOR TEMP. STIM receive FDA 510(k) clearance?

EXTERNAL PULSE GENERATOR FOR TEMP. STIM received FDA 510(k) clearance on 1983-12-16, under 510(k) number K831768.

Who is the listed applicant for EXTERNAL PULSE GENERATOR FOR TEMP. STIM?

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

What is the FDA product code for EXTERNAL PULSE GENERATOR FOR TEMP. STIM?

The FDA product code for EXTERNAL PULSE GENERATOR FOR TEMP. STIM is DTE.

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Other records listing Oscor, Inc. as applicant

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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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