FDA 510(k)

TIGER PULSE

K-Number: K830325 · 1983-03-01

Decision Date1983-03-01

Product CodeGZK

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

TIGER PULSE is the device name listed in this FDA 510(k) record. The listed applicant is Bertone & Assoc.. It received FDA 510(k) clearance on 1983-03-01 under 510(k) number K830325. The device is classified under product code GZK. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TIGER PULSE?

TIGER PULSE is a medical device that received FDA 510(k) clearance on 1983-03-01. The listed applicant is Bertone & Assoc.. The 510(k) number is K830325.

When did TIGER PULSE receive FDA 510(k) clearance?

TIGER PULSE received FDA 510(k) clearance on 1983-03-01, under 510(k) number K830325.

Who is the listed applicant for TIGER PULSE?

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

What is the FDA product code for TIGER PULSE?

The FDA product code for TIGER PULSE is GZK.

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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.