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FDA 510(k)

FIRST AMERICAN, RADIONIC, JKR, MODEL AC

K-Number: K881480 · 1988-08-11

ApplicantJkr Laboratories, Inc.
Decision Date1988-08-11
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

FIRST AMERICAN, RADIONIC, JKR, MODEL AC is the device name listed in this FDA 510(k) record. The listed applicant is Jkr Laboratories, Inc.. It received FDA 510(k) clearance on 1988-08-11 under 510(k) number K881480. The device is classified under product code ESD. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIRST AMERICAN, RADIONIC, JKR, MODEL AC?

FIRST AMERICAN, RADIONIC, JKR, MODEL AC is a medical device that received FDA 510(k) clearance on 1988-08-11. The listed applicant is Jkr Laboratories, Inc.. The 510(k) number is K881480.

When did FIRST AMERICAN, RADIONIC, JKR, MODEL AC receive FDA 510(k) clearance?

FIRST AMERICAN, RADIONIC, JKR, MODEL AC received FDA 510(k) clearance on 1988-08-11, under 510(k) number K881480.

Who is the listed applicant for FIRST AMERICAN, RADIONIC, JKR, MODEL AC?

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

What is the FDA product code for FIRST AMERICAN, RADIONIC, JKR, MODEL AC?

The FDA product code for FIRST AMERICAN, RADIONIC, JKR, MODEL AC is ESD.

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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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