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FDA 510(k)

HDRS-1 SYSTEM

K-Number: K915367 · 1992-04-06

ApplicantPrecision Radiation Measurement, Inc.
Decision Date1992-04-06
Product CodeJAQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HDRS-1 SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Precision Radiation Measurement, Inc.. It received FDA 510(k) clearance on 1992-04-06 under 510(k) number K915367. The device is classified under product code JAQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HDRS-1 SYSTEM?

HDRS-1 SYSTEM is a medical device that received FDA 510(k) clearance on 1992-04-06. The listed applicant is Precision Radiation Measurement, Inc.. The 510(k) number is K915367.

When did HDRS-1 SYSTEM receive FDA 510(k) clearance?

HDRS-1 SYSTEM received FDA 510(k) clearance on 1992-04-06, under 510(k) number K915367.

Who is the listed applicant for HDRS-1 SYSTEM?

The FDA 510(k) record lists Precision Radiation Measurement, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HDRS-1 SYSTEM?

The FDA product code for HDRS-1 SYSTEM is JAQ.

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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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