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FDA 510(k)

GRANSTAND

K-Number: K911608 · 1991-04-23

ApplicantPrime Engineering
Decision Date1991-04-23
Product CodeIPL
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

GRANSTAND is the device name listed in this FDA 510(k) record. The listed applicant is Prime Engineering. It received FDA 510(k) clearance on 1991-04-23 under 510(k) number K911608. The device is classified under product code IPL. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GRANSTAND?

GRANSTAND is a medical device that received FDA 510(k) clearance on 1991-04-23. The listed applicant is Prime Engineering. The 510(k) number is K911608.

When did GRANSTAND receive FDA 510(k) clearance?

GRANSTAND received FDA 510(k) clearance on 1991-04-23, under 510(k) number K911608.

Who is the listed applicant for GRANSTAND?

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

What is the FDA product code for GRANSTAND?

The FDA product code for GRANSTAND is IPL.

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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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