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FDA 510(k)

HDR 1000 PLUS WELL CHAMBER, MODEL 90008

K-Number: K060532 · 2006-04-11

ApplicantStandard Imaging, Inc.
Decision Date2006-04-11
Product CodeJAQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HDR 1000 PLUS WELL CHAMBER, MODEL 90008 is the device name listed in this FDA 510(k) record. The listed applicant is Standard Imaging, Inc.. It received FDA 510(k) clearance on 2006-04-11 under 510(k) number K060532. 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 HDR 1000 PLUS WELL CHAMBER, MODEL 90008?

HDR 1000 PLUS WELL CHAMBER, MODEL 90008 is a medical device that received FDA 510(k) clearance on 2006-04-11. The listed applicant is Standard Imaging, Inc.. The 510(k) number is K060532.

When did HDR 1000 PLUS WELL CHAMBER, MODEL 90008 receive FDA 510(k) clearance?

HDR 1000 PLUS WELL CHAMBER, MODEL 90008 received FDA 510(k) clearance on 2006-04-11, under 510(k) number K060532.

Who is the listed applicant for HDR 1000 PLUS WELL CHAMBER, MODEL 90008?

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

What is the FDA product code for HDR 1000 PLUS WELL CHAMBER, MODEL 90008?

The FDA product code for HDR 1000 PLUS WELL CHAMBER, MODEL 90008 is JAQ.

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Other records listing Standard Imaging, Inc. as applicant

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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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