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FDA 510(k)

CARDIAC SECTOR PROBE 5.0 MHZ

K-Number: K850216 · 1985-04-10

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date1985-04-10
Product CodeJOP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIAC SECTOR PROBE 5.0 MHZ is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 1985-04-10 under 510(k) number K850216. The device is classified under product code JOP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIAC SECTOR PROBE 5.0 MHZ?

CARDIAC SECTOR PROBE 5.0 MHZ is a medical device that received FDA 510(k) clearance on 1985-04-10. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K850216.

When did CARDIAC SECTOR PROBE 5.0 MHZ receive FDA 510(k) clearance?

CARDIAC SECTOR PROBE 5.0 MHZ received FDA 510(k) clearance on 1985-04-10, under 510(k) number K850216.

Who is the listed applicant for CARDIAC SECTOR PROBE 5.0 MHZ?

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

What is the FDA product code for CARDIAC SECTOR PROBE 5.0 MHZ?

The FDA product code for CARDIAC SECTOR PROBE 5.0 MHZ is JOP.

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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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