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FDA 510(k)

CADWELL FOUR-/EIGHT-CHANNEL PREAMPLIFIER

K-Number: K962458 · 1997-01-13

ApplicantCadwell Laboratories, Inc.
Decision Date1997-01-13
Product CodeGWF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

CADWELL FOUR-/EIGHT-CHANNEL PREAMPLIFIER is the device name listed in this FDA 510(k) record. The listed applicant is Cadwell Laboratories, Inc.. It received FDA 510(k) clearance on 1997-01-13 under 510(k) number K962458. The device is classified under product code GWF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CADWELL FOUR-/EIGHT-CHANNEL PREAMPLIFIER?

CADWELL FOUR-/EIGHT-CHANNEL PREAMPLIFIER is a medical device that received FDA 510(k) clearance on 1997-01-13. The listed applicant is Cadwell Laboratories, Inc.. The 510(k) number is K962458.

When did CADWELL FOUR-/EIGHT-CHANNEL PREAMPLIFIER receive FDA 510(k) clearance?

CADWELL FOUR-/EIGHT-CHANNEL PREAMPLIFIER received FDA 510(k) clearance on 1997-01-13, under 510(k) number K962458.

Who is the listed applicant for CADWELL FOUR-/EIGHT-CHANNEL PREAMPLIFIER?

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

What is the FDA product code for CADWELL FOUR-/EIGHT-CHANNEL PREAMPLIFIER?

The FDA product code for CADWELL FOUR-/EIGHT-CHANNEL PREAMPLIFIER is GWF.

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Other records listing Cadwell Laboratories, 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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