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FDA 510(k)

TRANSDUCER DOME SD105

K-Number: K833095 · 1983-11-03

ApplicantSorensen Research
Decision Date1983-11-03
Product CodeDRS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TRANSDUCER DOME SD105 is the device name listed in this FDA 510(k) record. The listed applicant is Sorensen Research. It received FDA 510(k) clearance on 1983-11-03 under 510(k) number K833095. The device is classified under product code DRS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRANSDUCER DOME SD105?

TRANSDUCER DOME SD105 is a medical device that received FDA 510(k) clearance on 1983-11-03. The listed applicant is Sorensen Research. The 510(k) number is K833095.

When did TRANSDUCER DOME SD105 receive FDA 510(k) clearance?

TRANSDUCER DOME SD105 received FDA 510(k) clearance on 1983-11-03, under 510(k) number K833095.

Who is the listed applicant for TRANSDUCER DOME SD105?

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

What is the FDA product code for TRANSDUCER DOME SD105?

The FDA product code for TRANSDUCER DOME SD105 is DRS.

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Other records listing Sorensen Research 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.

K833674ACCURATE MEASUREMENT DEVICE KG-AMDK833673ACCURATE MEASUREMENT DEVICE EZ-AMDK833096TRANSDUCER DOME DS106K833094TRANSDUCER DOME SD104K832957FLOW-DIRECTED HEPARIN COATED THERMODILK831506DISP. TRANSDUCER W/MONITORING KIT TRANS

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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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