FDA 510(k)

PACE 101H

K-Number: K970497 · 1997-06-04

Decision Date1997-06-04

Product CodeDTE

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

PACE 101H is the device name listed in this FDA 510(k) record. The listed applicant is Sulzer Oscor, Inc.. It received FDA 510(k) clearance on 1997-06-04 under 510(k) number K970497. 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 PACE 101H?

PACE 101H is a medical device that received FDA 510(k) clearance on 1997-06-04. The listed applicant is Sulzer Oscor, Inc.. The 510(k) number is K970497.

When did PACE 101H receive FDA 510(k) clearance?

PACE 101H received FDA 510(k) clearance on 1997-06-04, under 510(k) number K970497.

Who is the listed applicant for PACE 101H?

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

What is the FDA product code for PACE 101H?

The FDA product code for PACE 101H is DTE.

Other records listing Sulzer Oscor, 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.

K990142HT, MODEL HT PB

Related Devices (Code: DTE)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.