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FDA 510(k)

DISP. ACCESSORY TO EXTERNAL TRANS. CARDIAC PACE.

K-Number: K891122 · 1989-09-13

ApplicantBig Valley Medical
Decision Date1989-09-13
Product CodeLDD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DISP. ACCESSORY TO EXTERNAL TRANS. CARDIAC PACE. is the device name listed in this FDA 510(k) record. The listed applicant is Big Valley Medical. It received FDA 510(k) clearance on 1989-09-13 under 510(k) number K891122. The device is classified under product code LDD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISP. ACCESSORY TO EXTERNAL TRANS. CARDIAC PACE.?

DISP. ACCESSORY TO EXTERNAL TRANS. CARDIAC PACE. is a medical device that received FDA 510(k) clearance on 1989-09-13. The listed applicant is Big Valley Medical. The 510(k) number is K891122.

When did DISP. ACCESSORY TO EXTERNAL TRANS. CARDIAC PACE. receive FDA 510(k) clearance?

DISP. ACCESSORY TO EXTERNAL TRANS. CARDIAC PACE. received FDA 510(k) clearance on 1989-09-13, under 510(k) number K891122.

Who is the listed applicant for DISP. ACCESSORY TO EXTERNAL TRANS. CARDIAC PACE.?

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

What is the FDA product code for DISP. ACCESSORY TO EXTERNAL TRANS. CARDIAC PACE.?

The FDA product code for DISP. ACCESSORY TO EXTERNAL TRANS. CARDIAC PACE. is LDD.

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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.

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