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FDA 510(k)

ACCLAIM

K-Number: K832648 · 1983-09-20

ApplicantElectro-Nucleonics Laboratories, Inc.
Decision Date1983-09-20
Product CodeJJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACCLAIM is the device name listed in this FDA 510(k) record. The listed applicant is Electro-Nucleonics Laboratories, Inc.. It received FDA 510(k) clearance on 1983-09-20 under 510(k) number K832648. The device is classified under product code JJE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCLAIM?

ACCLAIM is a medical device that received FDA 510(k) clearance on 1983-09-20. The listed applicant is Electro-Nucleonics Laboratories, Inc.. The 510(k) number is K832648.

When did ACCLAIM receive FDA 510(k) clearance?

ACCLAIM received FDA 510(k) clearance on 1983-09-20, under 510(k) number K832648.

Who is the listed applicant for ACCLAIM?

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

What is the FDA product code for ACCLAIM?

The FDA product code for ACCLAIM is JJE.

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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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