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FDA 510(k)

MODEL 16800 TREND RECORDER

K-Number: K821612 · 1982-07-14

ApplicantHealthdyne, Inc.
Decision Date1982-07-14
Product CodeDSF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODEL 16800 TREND RECORDER is the device name listed in this FDA 510(k) record. The listed applicant is Healthdyne, Inc.. It received FDA 510(k) clearance on 1982-07-14 under 510(k) number K821612. The device is classified under product code DSF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL 16800 TREND RECORDER?

MODEL 16800 TREND RECORDER is a medical device that received FDA 510(k) clearance on 1982-07-14. The listed applicant is Healthdyne, Inc.. The 510(k) number is K821612.

When did MODEL 16800 TREND RECORDER receive FDA 510(k) clearance?

MODEL 16800 TREND RECORDER received FDA 510(k) clearance on 1982-07-14, under 510(k) number K821612.

Who is the listed applicant for MODEL 16800 TREND RECORDER?

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

What is the FDA product code for MODEL 16800 TREND RECORDER?

The FDA product code for MODEL 16800 TREND RECORDER is DSF.

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Related Devices (Code: DSF)

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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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