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FDA 510(k)

SOF SET, MODELS 111 AND 112

K-Number: K861436 · 1986-06-09

ApplicantPacesetter Systems
Decision Date1986-06-09
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SOF SET, MODELS 111 AND 112 is the device name listed in this FDA 510(k) record. The listed applicant is Pacesetter Systems. It received FDA 510(k) clearance on 1986-06-09 under 510(k) number K861436. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOF SET, MODELS 111 AND 112?

SOF SET, MODELS 111 AND 112 is a medical device that received FDA 510(k) clearance on 1986-06-09. The listed applicant is Pacesetter Systems. The 510(k) number is K861436.

When did SOF SET, MODELS 111 AND 112 receive FDA 510(k) clearance?

SOF SET, MODELS 111 AND 112 received FDA 510(k) clearance on 1986-06-09, under 510(k) number K861436.

Who is the listed applicant for SOF SET, MODELS 111 AND 112?

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

What is the FDA product code for SOF SET, MODELS 111 AND 112?

The FDA product code for SOF SET, MODELS 111 AND 112 is FRN.

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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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