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FDA 510(k)

MODEL 8400 W/MODIFICATIONS (SPECTRUM 32)

K-Number: K860801 · 1986-11-18

ApplicantCadwell Laboratories, Inc.
Decision Date1986-11-18
Product CodeGWE
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MODEL 8400 W/MODIFICATIONS (SPECTRUM 32) 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 1986-11-18 under 510(k) number K860801. The device is classified under product code GWE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL 8400 W/MODIFICATIONS (SPECTRUM 32)?

MODEL 8400 W/MODIFICATIONS (SPECTRUM 32) is a medical device that received FDA 510(k) clearance on 1986-11-18. The listed applicant is Cadwell Laboratories, Inc.. The 510(k) number is K860801.

When did MODEL 8400 W/MODIFICATIONS (SPECTRUM 32) receive FDA 510(k) clearance?

MODEL 8400 W/MODIFICATIONS (SPECTRUM 32) received FDA 510(k) clearance on 1986-11-18, under 510(k) number K860801.

Who is the listed applicant for MODEL 8400 W/MODIFICATIONS (SPECTRUM 32)?

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 MODEL 8400 W/MODIFICATIONS (SPECTRUM 32)?

The FDA product code for MODEL 8400 W/MODIFICATIONS (SPECTRUM 32) is GWE.

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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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