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FDA 510(k)

RAYDEN MEDICAL MINI PULSE VOLUME RECORD

K-Number: K833155 · 1984-01-26

ApplicantBurditt & Calkins-Siemens-Elema
Decision Date1984-01-26
Product CodeDSB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RAYDEN MEDICAL MINI PULSE VOLUME RECORD is the device name listed in this FDA 510(k) record. The listed applicant is Burditt & Calkins-Siemens-Elema. It received FDA 510(k) clearance on 1984-01-26 under 510(k) number K833155. The device is classified under product code DSB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RAYDEN MEDICAL MINI PULSE VOLUME RECORD?

RAYDEN MEDICAL MINI PULSE VOLUME RECORD is a medical device that received FDA 510(k) clearance on 1984-01-26. The listed applicant is Burditt & Calkins-Siemens-Elema. The 510(k) number is K833155.

When did RAYDEN MEDICAL MINI PULSE VOLUME RECORD receive FDA 510(k) clearance?

RAYDEN MEDICAL MINI PULSE VOLUME RECORD received FDA 510(k) clearance on 1984-01-26, under 510(k) number K833155.

Who is the listed applicant for RAYDEN MEDICAL MINI PULSE VOLUME RECORD?

The FDA 510(k) record lists Burditt & Calkins-Siemens-Elema as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RAYDEN MEDICAL MINI PULSE VOLUME RECORD?

The FDA product code for RAYDEN MEDICAL MINI PULSE VOLUME RECORD is DSB.

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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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